Status:
ACTIVE_NOT_RECRUITING
Identifying and Caring for Individuals With Inherited Cancer Syndrome
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Oregon Health and Science University
Conditions:
BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome
Breast Ductal Carcinoma In Situ
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This trial examines approaches to identify and care for individuals with inherited cancer syndrome. The purpose of this study is to offer no cost genetic testing to the general public. Researchers hop...
Detailed Description
PRIMARY OBJECTIVE: I. Evaluate the effectiveness and sustainability of heritable cancer syndrome testing in two proposed screening populations compared to current guidelines. SECONDARY OBJECTIVES: ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- ALL COHORTS: 18 years of age or older
- Retrospective COHORT A: Per HIPAA waiver, Retrospective Cohort A will not actively consent
- Retrospective COHORT A: Patients may or may not be diagnosed with cancer
- Retrospective COHORT A: Patients have received genetic counseling in the past 5 years
- Retrospective COHORT A: Patients have genetic variants that include BRCA1, BRCA2 and/or Lynch syndrome
- COHORT A: Per Health Insurance Portability and Accountability Act (HIPAA) waiver, Cohort A returns survey as consent
- COHORT A: Patients may or may not be diagnosed with cancer
- COHORT A: Patients have received genetic counseling in the past 1 - 2 years
- COHORT A: Patients have genetic variants that include BRCA1, BRCA2 and/or Lynch syndrome
- COHORT A: INCLUSIVE of no contact list to exclude from Cohort B
- COHORT B: Creation of secure Medable account
- COHORT B: Consent to this project, either hard or electronic signature
- COHORT B: Consent to the Healthy Oregon Project (HOP) repository, either hard or electronic signature
- COHORT B: Choosing to submit a deoxyribonucleic acid (DNA) sample
- COHORT B: Patients diagnosed with any National Cancer Institute (NCI)-reportable cancers, including ductal carcinoma in situ (DCIS) and/or in situ breast cancer
- COHORT B: Must have had an encounter within past twelve months
- COHORT B: Exclude Cohort A
- COHORT C: Creation of secure Medable account
- COHORT C: Consent to this project, either hard or electronic signature
- COHORT C: Consent to the HOP repository, either hard or electronic signature
- COHORT C: Choosing to submit a DNA sample
Exclusion
Key Trial Info
Start Date :
March 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 10 2030
Estimated Enrollment :
27500 Patients enrolled
Trial Details
Trial ID
NCT04494945
Start Date
March 9 2020
End Date
June 10 2030
Last Update
October 23 2025
Active Locations (2)
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1
Providence Portland Medical Center
Portland, Oregon, United States, 97213
2
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239