NCT04494945 Identifying and Caring for Individuals With Inherited Cancer Syndrome
| NCT ID | NCT04494945 |
| Status | Recruiting |
| Phase | — |
| Sponsor | OHSU Knight Cancer Institute |
| Condition | BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 27,500 participants |
| Start Date | 2020-03-09 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 27,500 participants in total. It began in 2020-03-09 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 hope to learn the value of providing broad, public-wide testing for high risk cancer types (like hereditary breast and ovarian cancer or Lynch syndromes) instead of only testing people whose families are known to be high risk.
Eligibility Criteria
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 Healthy Oregon Project (HOP) app account * COHORT B: Consent to this project, either hard or electronic signature * COHORT B: Consent to the 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 Hop app 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
Contact & Investigator
Jackilen Shannon, Ph.D.
PRINCIPAL INVESTIGATOR
OHSU Knight Cancer Institute
Frequently Asked Questions
Who can join the NCT04494945 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04494945 currently recruiting?
Yes, NCT04494945 is actively recruiting participants. Visit ClinicalTrials.gov or contact OHSU Knight Cancer Institute to inquire about joining.
Where is the NCT04494945 trial being conducted?
This trial is being conducted at Portland, United States, Portland, United States.
Who is sponsoring the NCT04494945 clinical trial?
NCT04494945 is sponsored by OHSU Knight Cancer Institute. The principal investigator is Jackilen Shannon, Ph.D. at OHSU Knight Cancer Institute. The trial plans to enroll 27,500 participants.
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