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@jeffdyke
Created November 11, 2021 22:13
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{'ArmsInterventionsModule': {'ArmGroupDescription': 'Female patients diagnosed '
'with hormone '
'receptor-positive (HR+), '
'lymph node-negative (LN-) '
'or lymph node-positive '
'(LN+, with 1-3 positive '
'nodes) early-stage '
'invasive breast cancer, '
'who are distant '
'recurrence-free.',
'ArmGroupInterventionName': 'Diagnostic Test: '
'Breast Cancer Index '
'(BCI) Risk of '
'Recurrence & '
'Extended Endocrine '
'Benefit Test',
'ArmGroupLabel': 'Breast Cancer Index (BCI) Risk '
'of Recurrence & Extended '
'Endocrine Benefit Testing',
'InterventionArmGroupLabel': 'Breast Cancer Index '
'(BCI) Risk of '
'Recurrence & '
'Extended Endocrine '
'Benefit Testing',
'InterventionDescription': None,
'InterventionName': None,
'InterventionType': None},
'ConditionsModule': {'Condition': 'Breast Cancer',
'Keywords': 'Breast Neoplasm'},
'ContactsLocationsModule': {'CentralContact': [{'CentralContactEMail': 'brandon.oneal@biotheranostics.com',
'CentralContactName': 'Brandon '
'N '
"O'Neal, "
'MS',
'CentralContactPhone': '858-314-9304',
'CentralContactRole': 'Contact'}],
'Location': [{'LocationCity': 'Daphne',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'karla.childers@usoncology.com',
'LocationContactName': 'Karla '
'Childers',
'LocationContactPhone': '251-433-9899',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Michael '
'Meshad, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Southern '
'Cancer Center, '
'P.C. - Daphne',
'LocationState': 'Alabama',
'LocationStatus': 'Recruiting',
'LocationZip': '36526'},
{'LocationCity': 'Mobile',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'karla.childers@usoncology.com',
'LocationContactName': 'Karla '
'Childers',
'LocationContactPhone': '251-433-9899',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Michael '
'Meshad, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Southern '
'Cancer Center, '
'PC - Mobile '
'Infirmary',
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'LocationStatus': 'Recruiting',
'LocationZip': '36607'},
{'LocationCity': 'Mobile',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'karla.childers@usoncology.com',
'LocationContactName': 'Karla '
'Childers',
'LocationContactPhone': '251-433-9899',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Michael '
'Meshad, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Southern '
'Cancer Center, '
'PC - '
'Providence '
'Hospital',
'LocationState': 'Alabama',
'LocationStatus': 'Recruiting',
'LocationZip': '36608'},
{'LocationCity': 'Mobile',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'karla.childers@usoncology.com',
'LocationContactName': 'Karla '
'Childers',
'LocationContactPhone': '251-433-9899',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Michael '
'Meshad, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Southern '
'Cancer Center, '
'PC - '
'Springhill '
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'LocationStatus': 'Recruiting',
'LocationZip': '36608'},
{'LocationCity': 'Glendale',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'theresa.thomas@usoncology.com',
'LocationContactName': 'Theresa '
'Thomas',
'LocationContactPhone': '623-487-4822',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Govardhanan '
'Nagaiah, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Arizona '
'Oncology '
'Associates, PC '
'- Glendale - '
'Saguaro Cancer '
'Center',
'LocationState': 'Arizona',
'LocationStatus': 'Recruiting',
'LocationZip': '85308'},
{'LocationCity': 'Goodyear',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'theresa.thomas@usoncology.com',
'LocationContactName': 'Theresa '
'Thomas',
'LocationContactPhone': '623-269-4222',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Govardhanan '
'Nagaiah, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Arizona '
'Oncology '
'Associates, PC '
'- Goodyear',
'LocationState': 'Arizona',
'LocationStatus': 'Recruiting',
'LocationZip': '85395'},
{'LocationCity': 'Phoenix',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'theresa.thomas@usoncology.com',
'LocationContactName': 'Theresa '
'Thomas',
'LocationContactPhone': '602-277-4868',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Govardhanan '
'Nagaiah, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Arizona '
'Oncology '
'Associates, PC '
'- Phoenix - '
'Biltmore '
'Cancer Center',
'LocationState': 'Arizona',
'LocationStatus': 'Recruiting',
'LocationZip': '85016'},
{'LocationCity': 'Phoenix',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'theresa.thomas@usoncology.com',
'LocationContactName': 'Theresa '
'Thomas',
'LocationContactPhone': '623-879-4419',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Govardhanan '
'Nagaiah, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Arizona '
'Oncology '
'Associates, PC '
'- Phoenix - '
'Deer Valley',
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'LocationStatus': 'Recruiting',
'LocationZip': '85027'},
{'LocationCity': 'Scottsdale',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'theresa.thomas@usoncology.com',
'LocationContactName': 'Theresa '
'Thomas',
'LocationContactPhone': '480-860-2540',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Govardhanan '
'Nagaiah, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Arizona '
'Oncology '
'Associates, PC '
'- Scottsdale',
'LocationState': 'Arizona',
'LocationStatus': 'Recruiting',
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{'LocationCity': 'Tempe',
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'LocationContactName': 'Theresa '
'Thomas',
'LocationContactPhone': '480-256-1664',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Govardhanan '
'Nagaiah, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Arizona '
'Oncology '
'Associates, PC '
'- East Valley '
'Cancer Center',
'LocationState': 'Arizona',
'LocationStatus': 'Recruiting',
'LocationZip': '85284'},
{'LocationCity': 'Santa Barbara',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'hheitkam@ridleytreecc.org',
'LocationContactName': 'Heidi '
'Heitkamp',
'LocationContactPhone': '805-879-0670',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Gregg '
'C '
'Newman, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Sansum Clinic '
'- Ridley-Tree '
'Cancer Center',
'LocationState': 'California',
'LocationStatus': 'Recruiting',
'LocationZip': '93105'},
{'LocationCity': 'Solvang',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'hheitkam@ridleytreecc.org',
'LocationContactName': 'Heidi '
'Heitkamp',
'LocationContactPhone': '805-686-5370',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Gregg '
'C '
'Newman, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Sansum Clinic '
'- Ridley-Tree '
'Cancer Center '
'(Solvang)',
'LocationState': 'California',
'LocationStatus': 'Recruiting',
'LocationZip': '93463'},
{'LocationCity': 'Aurora',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'kelly.beland@usoncology.com',
'LocationContactName': 'Kelly '
'Beland',
'LocationContactPhone': '303-418-7639',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Jenny '
'R '
'Fox, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Rocky Mountain '
'Cancer Center '
'- Aurora',
'LocationState': 'Colorado',
'LocationStatus': 'Recruiting',
'LocationZip': '80012'},
{'LocationCity': 'Boulder',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'kelly.beland@usoncology.com',
'LocationContactName': 'Kelly '
'Beland',
'LocationContactPhone': '303-385-2000',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Jenny '
'R '
'Fox, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Rocky Mountain '
'Cancer Center '
'- Boulder',
'LocationState': 'Colorado',
'LocationStatus': 'Recruiting',
'LocationZip': '80303'},
{'LocationCity': 'Centennial',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'kelly.beland@usoncology.com',
'LocationContactName': 'Kelly '
'Beland',
'LocationContactPhone': '303-805-7744',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Jenny '
'R '
'Fox, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
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'Cancer Center '
'- Centennial',
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'LocationZip': '80112'},
{'LocationCity': 'Colorado Springs',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'kelly.beland@usoncology.com',
'LocationContactName': 'Kelly '
'Beland',
'LocationContactPhone': '719-577-2555',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Jenny '
'R '
'Fox, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Rocky Mountain '
'Cancer Center '
'- Colorado '
'Springs',
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'LocationStatus': 'Recruiting',
'LocationZip': '80907'},
{'LocationCity': 'Denver',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'kelly.beland@usoncology.com',
'LocationContactName': 'Kelly '
'Beland',
'LocationContactPhone': '303-388-4876',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Jenny '
'R '
'Fox, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
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'Cancer Center '
'- Denver '
'Midtown',
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'LocationStatus': 'Recruiting',
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{'LocationCity': 'Denver',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'kelly.beland@usoncology.com',
'LocationContactName': 'Kelly '
'Beland',
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'LocationContactRole': 'Contact'},
{'LocationContactName': 'Jenny '
'R '
'Fox, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
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'Cancer Center '
'- Denver',
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{'LocationCity': 'Englewood',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'kelly.beland@usoncology.com',
'LocationContactName': 'Kelly '
'Beland',
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{'LocationContactName': 'Jenny '
'R '
'Fox, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
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'Cancer Center '
'- Swedish '
'Medical Center',
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{'LocationCity': 'Lakewood',
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'Beland',
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'LocationContactRole': 'Contact'},
{'LocationContactName': 'Jenny '
'R '
'Fox, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
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{'LocationCity': 'Littleton',
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'LocationContactName': 'Kelly '
'Beland',
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{'LocationContactName': 'Jenny '
'R '
'Fox, '
'MD',
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'LocationCountry': 'United States',
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{'LocationCity': 'Lone Tree',
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{'LocationContactName': 'Jenny '
'R '
'Fox, '
'MD',
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'LocationCountry': 'United States',
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'Cancer Center '
'- Lone Tree',
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{'LocationCity': 'Longmont',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'kelly.beland@usoncology.com',
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{'LocationContactName': 'Jenny '
'R '
'Fox, '
'MD',
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'Cancer Center '
'- Longmont',
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{'LocationCity': 'Pueblo',
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{'LocationContactName': 'Jenny '
'R '
'Fox, '
'MD',
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'Investigator'}]},
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'Cancer Center '
'- Pueblo',
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{'LocationCity': 'Thornton',
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'LocationContactName': 'Kelly '
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{'LocationContactName': 'Jenny '
'R '
'Fox, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
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'Cancer Center '
'- Thornton',
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'LocationStatus': 'Recruiting',
'LocationZip': '80260'},
{'LocationCity': 'Palm Bay',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'deborah.schmitt@usoncology.com',
'LocationContactName': 'Deborah '
'Schmitt',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Venkat '
'Pavan '
'R '
'Kancharla, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Cancer Care '
'Centers of '
'Brevard, Inc.',
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'LocationStatus': 'Recruiting',
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{'LocationCity': 'Arlington Heights',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'andrea.glidden@usoncology.com',
'LocationContactName': 'Andrea '
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'LocationContactRole': 'Contact'},
{'LocationContactEMail': 'laura.palmisano@usoncology.com',
'LocationContactName': 'Laura '
'Palmisano',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Kristen '
'B '
'Wendell, '
'DO',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Illinois '
'Cancer '
'Specialists - '
'Arlington '
'Heights',
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'LocationZip': '60005'},
{'LocationCity': 'Niles',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'lisbeth.lynn@usoncology.com',
'LocationContactName': 'Lisbeth '
'B '
'Lynn',
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'LocationContactRole': 'Contact'},
{'LocationContactEMail': 'sara.majcher@usoncology.com',
'LocationContactName': 'Sara '
'Majcher',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Kristen '
'B '
'Wendell, '
'DO',
'LocationContactRole': 'Principal '
'Investigator'}]},
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'LocationFacility': 'Illinois '
'Cancer '
'Specialists - '
'Niles',
'LocationState': 'Illinois',
'LocationStatus': 'Recruiting',
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{'LocationCity': 'Bethesda',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'missy.almand@usoncology.com',
'LocationContactName': 'Melissa '
'Almand',
'LocationContactPhone': '301-424-6231',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Carolyn '
'Hendricks, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Maryland '
'Oncology '
'Hematology, '
'P.A. - '
'Bethesda',
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{'LocationCity': 'Brandywine',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'missy.almand@usoncology.com',
'LocationContactName': 'Melissa '
'Almand',
'LocationContactPhone': '301-812-3900',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Carolyn '
'Hendricks, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Maryland '
'Oncology '
'Hematology, '
'P.A. - '
'Brandywine',
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'LocationContactName': 'Melissa '
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'LocationContactPhone': '301-868-7911',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Carolyn '
'Hendricks, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Maryland '
'Oncology '
'Hematology, '
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{'LocationCity': 'Columbia',
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'LocationContactRole': 'Contact'},
{'LocationContactName': 'Carolyn '
'Hendricks, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
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'Oncology '
'Hematology, '
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'Columbia',
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{'LocationCity': 'Frederick',
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'LocationContactName': 'Melissa '
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'LocationContactRole': 'Contact'},
{'LocationContactName': 'Carolyn '
'Hendricks, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Maryland '
'Oncology '
'Hematology, '
'P.A. - '
'Frederick',
'LocationState': 'Maryland',
'LocationStatus': 'Recruiting',
'LocationZip': '21702'},
{'LocationCity': 'Lanham',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'missy.almand@usoncology.com',
'LocationContactName': 'Melissa '
'Almand',
'LocationContactPhone': '301-474-0427',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Carolyn '
'Hendricks, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Maryland '
'Oncology '
'Hematology, '
'P.A. - Lanham',
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'LocationStatus': 'Recruiting',
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{'LocationCity': 'Rockville',
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'LocationContactName': 'Melissa '
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'LocationContactRole': 'Contact'},
{'LocationContactName': 'Carolyn '
'Hendricks, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Maryland '
'Oncology '
'Hematology, '
'P.A. - '
'Rockville - '
'Aquilino '
'Cancer Center',
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{'LocationCity': 'Silver Spring',
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'LocationContactName': 'Melissa '
'Almand',
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'LocationContactRole': 'Contact'},
{'LocationContactName': 'Carolyn '
'Hendricks, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Maryland '
'Oncology '
'Hematology, '
'P.A. - Silver '
'Spring - White '
'Oak Cancer '
'Center',
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'LocationStatus': 'Recruiting',
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{'LocationCity': 'Albany',
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'LocationContactName': 'Amy '
'Zuchelkowski',
'LocationContactPhone': '518-489-2607',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Karen '
'L '
'Tedesco, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
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'Oncology '
'Hematology, '
'P.C. - Albany '
'Cancer Center',
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{'LocationCity': 'Albany',
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'LocationContactPhone': '281-332-7505',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Dhatri '
'Kodali, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Texas Oncology '
'- Deke Slayton '
'Cancer Center',
'LocationState': 'Texas',
'LocationStatus': 'Recruiting',
'LocationZip': '77598'},
{'LocationCity': 'Weslaco',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'nereida.salinas@usoncology.com',
'LocationContactName': 'Nereida '
'Salinas',
'LocationContactPhone': '956-969-0021',
'LocationContactRole': 'Contact'},
{'LocationContactEMail': 'aide.borrego@usoncology.com',
'LocationContactName': 'Aide '
'Borrego',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Alvaro '
'Restrepo, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Texas Oncology '
'- Weslaco',
'LocationState': 'Texas',
'LocationStatus': 'Recruiting',
'LocationZip': '78596'},
{'LocationCity': 'Alexandria',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'marcy.sullivan@usoncology.com',
'LocationContactName': 'Marcy '
'Sullivan',
'LocationContactPhone': '703-832-5322',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Mitul '
'Gandhi, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Virginia '
'Cancer '
'Specialists, '
'PC - '
'Alexandria',
'LocationState': 'Virginia',
'LocationStatus': 'Recruiting',
'LocationZip': '22304'},
{'LocationCity': 'Arlington',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'marcy.sullivan@usoncology.com',
'LocationContactName': 'Marcy '
'Sullivan',
'LocationContactPhone': '703-528-7303',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Mitul '
'Gandhi, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Virginia '
'Cancer '
'Specialists, '
'PC - Arlington',
'LocationState': 'Virginia',
'LocationStatus': 'Recruiting',
'LocationZip': '22205'},
{'LocationCity': 'Fairfax',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'marcy.sullivan@usoncology.com',
'LocationContactName': 'Marcy '
'Sullivan',
'LocationContactPhone': '703-280-5390',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Mitul '
'Gandhi, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Virginia '
'Cancer '
'Specialists, '
'PC - Fairfax',
'LocationState': 'Virginia',
'LocationStatus': 'Recruiting',
'LocationZip': '22031'},
{'LocationCity': 'Gainesville',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'marcy.sullivan@usoncology.com',
'LocationContactName': 'Marcy '
'Sullivan',
'LocationContactPhone': '571-222-2200',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Mitul '
'Gandhi, '
'MD',
'LocationContactRole': 'Sub-Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Virginia '
'Cancer '
'Specialists, '
'PC - '
'Gainesville',
'LocationState': 'Virginia',
'LocationStatus': 'Recruiting',
'LocationZip': '20155'},
{'LocationCity': 'Leesburg',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'marcy.sullivan@usoncology.com',
'LocationContactName': 'Marcy '
'Sullivan',
'LocationContactPhone': '703-554-6800',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'Mitul '
'Gandhi, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Virginia '
'Cancer '
'Specialists, '
'PC - Loudoun',
'LocationState': 'Virginia',
'LocationStatus': 'Recruiting',
'LocationZip': '20176'},
{'LocationCity': 'Winchester',
'LocationContactList': {'LocationContact': [{'LocationContactEMail': 'william.houck@usoncology.com',
'LocationContactName': 'William '
'A '
'Houck '
'III, '
'MD',
'LocationContactPhone': '540-662-1108',
'LocationContactRole': 'Contact'},
{'LocationContactName': 'William '
'A '
'Houck '
'III, '
'MD',
'LocationContactRole': 'Principal '
'Investigator'}]},
'LocationCountry': 'United States',
'LocationFacility': 'Shenandoah '
'Oncology, P.C.',
'LocationState': 'Virginia',
'LocationStatus': 'Recruiting',
'LocationZip': '22601'}],
'OverallOfficial': [{'OverallOfficialAffiliation': 'US '
'Oncology '
'Network',
'OverallOfficialName': 'Joyce '
'A '
"O'Shaughnessy, "
'MD',
'OverallOfficialRole': 'Principal '
'Investigator'},
{'OverallOfficialAffiliation': 'Biotheranostics, '
'Inc.',
'OverallOfficialName': 'Catherine '
'A '
'Schnabel, '
'PhD',
'OverallOfficialRole': 'Study '
'Director'},
{'OverallOfficialAffiliation': 'Biotheranostics, '
'Inc.',
'OverallOfficialName': 'Kai '
'Treuner, '
'PhD',
'OverallOfficialRole': 'Study '
'Director'}]},
'DescriptionModule': {'BriefSummary': 'The purpose of the Breast Cancer Index '
'(BCI) Registry study is to conduct a '
'large scale, population-based '
'prospective registry to evaluate '
'long-term clinical outcome, clinical '
'impact, medication adherence and '
'quality of life in hormone receptor '
'positive (HR+) early-stage breast '
'cancer patients receiving BCI testing '
'as part of routine clinical care to '
'inform extended endocrine therapy.',
'DetailedDescription': 'The BCI Registry is designed as '
'a large-scale data registry and '
'biospecimen repository to '
'evaluate the clinical outcome '
'of hormone receptor positive '
'(HR+) early-stage breast cancer '
'patients completing primary '
'adjuvant endocrine therapy and '
'are considering extended '
'endocrine treatment. The impact '
'of BCI test results on extended '
'endocrine therapy '
'decision-making and clinical '
'use patterns will be '
'characterized. Extended '
'endocrine therapy-specific '
'medication adherence will be '
'assessed annually. Primary '
'tumor tissue will be collected '
'for scientific research '
'purposes including molecular '
'profiling and for correlative '
'studies. The sample size will '
'consist of approximately 3,000 '
'subjects across 30-50 sites in '
'the United States.\n'
'\n'
'The BCI registry will recruit '
'patients with HR+ stage I to '
'III breast cancer following an '
'initial 4-7 years of adjuvant '
'endocrine therapy that will '
'have BCI testing performed as '
'part of routine clinical care '
'and meet the '
'inclusion/exclusion criteria. '
'After signing the informed '
'consent form (ICF) during '
'screening, physicians and '
'patients will complete the '
'pre-test Decision Impact '
'Questionnaire. Upon ordering '
'BCI by the treating physician, '
'primary tumor tissue obtained '
'from the patient during '
'previous breast-conserving '
'surgery or mastectomy will be '
'requested by Biotheranostics to '
'perform BCI testing at '
"Biotheranostics' CLIA certified "
'and CAP accredited clinical '
'laboratory in San Diego, CA. '
'Following BCI testing, the '
'physician will share and '
'discuss the BCI results with '
'their patients and recommend to '
'either stop or extend endocrine '
'therapy for an additional 5 '
'years. The impact of the BCI '
'test results on extended '
'endocrine therapy '
'decision-making will be '
'assessed using the post-test '
'Decision Impact Questionnaire, '
'which will be completed by both '
'physicians and patients. In '
'addition, medication adherence '
'will be evaluated in patients '
'that are recommended for or '
'elect to continue treatment to '
'complete 10 years of adjuvant '
'endocrine therapy.\n'
'\n'
'BCI reports both a prognostic '
'and predictive result and has '
'been shown to significantly '
'stratify patients based on the '
'risk of late distant recurrence '
'as well as to predict the '
'likelihood of benefit from '
'endocrine therapy in multiple '
'prospective-retrospective '
'studies within randomized '
'controlled trial cohorts. The '
'BCI registry study will '
'determine the long-term outcome '
'and BCI test performance to add '
'prospective validation for the '
'prognostic and predictive '
'capabilities of BCI. In this '
'context, the impact of BCI test '
'results on treatment '
'decision-making and '
'subsequently prescribed '
'treatments will be '
'characterized.\n'
'\n'
'Analysis of BCI test '
'performance with long-term '
'outcome will be performed by '
'Kaplan-Meier analysis with '
'log-rank test to assess the '
'statistical significance of the '
'risk stratification by BCI risk '
'groups. Cox proportional '
'hazards regression will be used '
'to derive the hazard ratios '
'(HR) and the associated 95% '
'confidence intervals for the '
'comparison of BCI risk groups. '
'Univariate and multivariate '
'analysis adjusting for clinical '
'factors such as age, tumor '
'size, grade, and treatment '
'background (adjuvant endocrine '
'therapy and chemotherapy) will '
'be conducted. Descriptive '
'statistics will be used to '
'evaluate the decision-impact '
'and medication adherence scores '
'of patients enrolled in the '
'study.\n'
'\n'
'Each participating site will '
'maintain appropriate medical '
'and research records for this '
'trial, in compliance with '
'Section 4.9 of the ICH E6 GCP, '
'and regulatory and '
'institutional requirements for '
'the protection of '
'confidentiality of subjects. As '
'part of participating in a '
'Biotheranostics-sponsored '
'study, each site will permit '
'authorized representatives of '
'the sponsor and regulatory '
'agencies to examine clinical '
'records for the purposes of '
'quality assurance reviews, '
'audits and evaluation of the '
'study progress. The clinical '
'trial manager will be in '
'regular contact with the site '
'research leader to check on '
'progress and address any '
'queries that they may have. '
'Sites may be suspended from '
'participating in the registry '
'in the event of serious and '
'persistent non-compliance with '
'the protocol and/or Good '
'Clinical Practice. Any major '
'problems identified will be '
'reported to the Trial '
'Management Team and if '
'necessary, the relevant '
'regulatory bodies.'},
'DesignModule': {},
'EligibilityModule': {'ExclusionCriteria': 'Patient has distant metastatic '
'disease (m1).Patient was '
'diagnosed with metaplastic breast '
'cancer, carcinosarcoma, sarcoma, '
'neuroendocrine carcinoma, adenoid '
'cystic carcinoma, or phyllodes '
'tumor.',
'Gender': 'Female',
'GenderBased': 'Yes',
'HealthyVolunteers': 'No',
'InclusionCriteria': 'Early stage (i, ii or iii) female '
'breast cancer patients, who have '
'completed 4-7 years of primary '
'adjuvant endocrine therapyPatient '
'was diagnosed with invasive '
'breast carcinoma (ductal, '
'lobular, or mixed '
'ductal/lobular).The primary tumor '
'was hormone receptor positive '
'(hr+), i.e. estrogen '
'receptor-positive and/or '
'progesterone '
'receptor-positive.The primary '
'tumor was her2 negative or '
'positive and node-negative or '
'node-positive with 1-3 positive '
'lymph nodes.Subject has '
'pre-treatment breast tumor tissue '
'[formalin fixed and paraffin '
'embedded (ffpe)] from a previous '
'breast-conserving surgery, '
'mastectomy or core needle biopsy '
'available for testing by the '
'sponsor.',
'MinimumAge': '18 Years',
'SamplingMethod': 'Non-Probability Sample',
'StdAge': 'Adult - Older Adult',
'StudyPopulation': 'The study will include patients '
'with stage I-III HR+ breast cancer '
'that have signed an informed '
'consent. Patients seen within a '
'physician practice participating in '
'the registry are potential '
'candidates after meeting '
'eligibility criteria requirements.'},
'IdentificationModule': {'BriefTitle': 'Breast Cancer Index (BCI) Registry',
'NCTId': 'NCT04875351',
'OfficialTitle': 'Breast Cancer Index (BCI) Registry',
'OrgStudyId': 'BTX-BCI-016-PRT',
'OrganizationClass': 'INDUSTRY',
'OrganizationFullName': 'Biotheranostics, Inc.'},
'OutcomesModule': {'PrimaryOutcome': {'PrimaryOutcomeMeasure': 'To determine '
'BCI test '
'performance '
'by evaluating '
'the long-term '
'outcome of '
'BCI risk '
'groups over '
'the follow-up '
'period.',
'PrimaryOutcomeTimeFrame': '5 Years'},
'SecondaryOutcomeDescription': {'SecondaryOutcomeDescription': 'The '
'impact '
'of '
'the '
'BCI '
'test '
'results '
'on '
'extended '
'endocrine '
'therapy '
'decision '
'making '
'will '
'be '
'measured '
'using '
'pre- '
'and '
'post-test '
'Decision '
'Impact '
'Questionnaires, '
'which '
'will '
'be '
'completed '
'by '
'both '
'physicians '
'and '
'patients.',
'SecondaryOutcomeMeasure': 'To '
'prospectively '
'assess '
'the '
'impact '
'of '
'BCI '
'on '
'extended '
'endocrine '
'therapy '
'decision-making.',
'SecondaryOutcomeTimeFrame': '5 '
'Years'}},
'ReferencesModule': {'References': [{'ReferenceCitation': 'Noordhoek I, '
'Treuner K, Putter '
'H, Zhang Y, Wong '
'J, Meershoek-Klein '
'Kranenbarg E, '
'Duijm-de '
'Carpentier M, van '
'de Velde CJH, '
'Schnabel CA, '
'Liefers GJ. Breast '
'Cancer Index '
'Predicts Extended '
'Endocrine Benefit '
'to Individualize '
'Selection of '
'Patients with '
'HR(+) Early-stage '
'Breast Cancer for '
'10 Years of '
'Endocrine Therapy. '
'Clin Cancer Res. '
'2021 Jan '
'1;27(1):311-319. '
'doi: '
'10.1158/1078-0432.CCR-20-2737. '
'Epub 2020 Oct 27.',
'ReferencePMID': '33109739',
'ReferenceType': 'background'},
{'ReferenceCitation': 'Bartlett JMS, '
'Sgroi DC, Treuner '
'K, Zhang Y, Ahmed '
'I, Piper T, '
'Salunga R, '
'Brachtel EF, '
'Pirrie SJ, '
'Schnabel CA, Rea '
'DW. Breast Cancer '
'Index and '
'prediction of '
'benefit from '
'extended endocrine '
'therapy in breast '
'cancer patients '
'treated in the '
'Adjuvant '
'Tamoxifen-To Offer '
'More? (aTTom) '
'trial. Ann Oncol. '
'2019 Nov '
'1;30(11):1776-1783. '
'doi: '
'10.1093/annonc/mdz289.',
'ReferencePMID': '31504126',
'ReferenceType': 'background'},
{'ReferenceCitation': 'Zhang Y, Schnabel '
'CA, Schroeder BE, '
'Jerevall PL, '
'Jankowitz RC, '
'Fornander T, Stål '
'O, Brufsky AM, '
'Sgroi D, Erlander '
'MG. Breast cancer '
'index identifies '
'early-stage '
'estrogen '
'receptor-positive '
'breast cancer '
'patients at risk '
'for early- and '
'late-distant '
'recurrence. Clin '
'Cancer Res. 2013 '
'Aug '
'1;19(15):4196-205. '
'doi: '
'10.1158/1078-0432.CCR-13-0804. '
'Epub 2013 Jun 11.',
'ReferencePMID': '23757354',
'ReferenceType': 'background'},
{'ReferenceCitation': 'Sgroi DC, Sestak '
'I, Cuzick J, Zhang '
'Y, Schnabel CA, '
'Schroeder B, '
'Erlander MG, '
'Dunbier A, Sidhu '
'K, Lopez-Knowles '
'E, Goss PE, '
'Dowsett M. '
'Prediction of late '
'distant recurrence '
'in patients with '
'oestrogen-receptor-positive '
'breast cancer: a '
'prospective '
'comparison of the '
'breast-cancer '
'index (BCI) assay, '
'21-gene recurrence '
'score, and IHC4 in '
'the TransATAC '
'study population. '
'Lancet Oncol. 2013 '
'Oct;14(11):1067-1076. '
'doi: '
'10.1016/S1470-2045(13)70387-5. '
'Epub 2013 Sep 12. '
'Erratum in: Lancet '
'Oncol. 2018 '
'Apr;19(4):e184.',
'ReferencePMID': '24035531',
'ReferenceType': 'background'},
{'ReferenceCitation': 'Sgroi DC, Carney '
'E, Zarrella E, '
'Steffel L, Binns '
'SN, Finkelstein '
'DM, Szymonifka J, '
'Bhan AK, Shepherd '
'LE, Zhang Y, '
'Schnabel CA, '
'Erlander MG, Ingle '
'JN, Porter P, Muss '
'HB, Pritchard KI, '
'Tu D, Rimm DL, '
'Goss PE. '
'Prediction of late '
'disease recurrence '
'and extended '
'adjuvant letrozole '
'benefit by the '
'HOXB13/IL17BR '
'biomarker. J Natl '
'Cancer Inst. 2013 '
'Jul '
'17;105(14):1036-42. '
'doi: '
'10.1093/jnci/djt146. '
'Epub 2013 Jun 28.',
'ReferencePMID': '23812955',
'ReferenceType': 'background'}]},
'SponsorCollaboratorsModule': {'LeadSponsorClass': 'INDUSTRY',
'LeadSponsorName': 'Biotheranostics, Inc.',
'ResponsiblePartyType': 'Sponsor'},
'StatusModule': {'ExpandedAccess': 'No',
'LastKnownStatus': None,
'LastUpdatePostDate': 'May 25, 2021',
'LastUpdatePostDateType': 'Actual',
'LastUpdateSubmitDate': 'May 24, 2021',
'OverallStatus': 'Recruiting',
'PrimaryCompletionDate': 'December 2028',
'PrimaryCompletionDateType': 'Anticipated',
'StartDate': 'April 14, 2021',
'StatusVerifiedDate': 'May 2021',
'StudyFirstPostDate': 'May 6, 2021',
'StudyFirstPostDateType': 'Actual',
'StudyFirstSubmitDate': 'April 26, 2021'}}
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