Identifying and caring for individuals with inherited cancer syndromes
Approaches to Identify and Care for Individuals With Inherited Cancer Syndromes
This study is testing whether free genetic testing can help find and support people with inherited cancer syndromes better than current methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 27500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | OHSU Knight Cancer Institute Academic / other |
| Locations | 2 sites (Portland, Oregon and 1 other locations) |
| Trial ID | NCT04494945 on ClinicalTrials.gov |
What this trial studies
This trial focuses on identifying and providing care for individuals with inherited cancer syndromes by offering no-cost genetic testing to the general public. The study aims to evaluate the effectiveness and sustainability of heritable cancer syndrome testing in different screening populations compared to current guidelines. Participants will provide saliva samples for genetic testing, and if positive, will receive genetic counseling. Additionally, participants will complete a survey regarding cancer prevention, screening, and treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older who may have genetic variants associated with BRCA1, BRCA2, or Lynch syndrome.
Not a fit: Patients without a family history of cancer or those who do not meet the genetic criteria for testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early detection and management of hereditary cancer syndromes, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown success with similar genetic testing approaches, indicating potential for effective implementation in broader populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Portland, Oregon and 1 other locations
- Providence Portland Medical Center — Portland, Oregon, United States (Recruiting)
- OHSU Knight Cancer Institute — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Jackilen Shannon, Ph.D. — OHSU Knight Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.