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Identifying and Caring for Individuals With Inherited Cancer Syndrome

This study is looking at new ways to find and care for people who have inherited cancer syndromes, like those linked to BRCA1/2 genes or Lynch Syndrome. The main goal is to offer free genetic testing to the general public. Researchers want to see if offering widespread testing for high-risk cancers is more effective than only testing people with a known family history. If your genetic test is positive, you will receive genetic counseling. The study aims to understand how well this approach works and if people follow recommended care for these conditions. This study is currently unclear on its recruitment status and plans to enroll 27,500 participants.

Study design
This interventional study plans to enroll 27,500 participants. It will compare the effectiveness of genetic testing in two new populations against current guidelines.
What's involved
You would provide a saliva sample for genetic testing and complete a survey. If your test is positive, you will receive genetic counseling.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes related to testing effectiveness, adherence to care, and risk reduction strategies for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04494945

Identifying and Caring for Individuals With Inherited Cancer Syndrome

Recruiting
NAAges 18+InterventionalScreening
OHSU Knight Cancer Institute
~27,500 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Biospecimen CollectionGenetic CounselingGenetic TestingSurvey Administration

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations
Measured over Up to 5 years
+3 more outcomes measured

Conditions

BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome
Breast Ductal Carcinoma In Situ
Hematopoietic and Lymphoid System Neoplasm
Hereditary Neoplastic Syndrome
Lynch Syndrome
Malignant Solid Neoplasm

Explore related trials

Breast CarcinomaHematologic NeoplasmHereditary Neoplastic SyndromeLynch SyndromeSolid NeoplasmBRCA1 GeneBRCA2 GeneLynch Syndrome

Where it's being run

2 sites across 1 states
Oregon2

Study leadership

  • Jackilen Shannon, Ph.D. · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute

Who to contact

Bill J. Wright, Ph.D.
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populationsUp to 5 years

    Determine the costs and effectiveness, specifically Quality Adjusted Life Years (QALYs) associated with genetic screening models based on Cohorts B and C to estimate incremental cost-effectiveness ratio (ICER) and show that the costs per QALY are below the acceptable cost effectiveness threshold.

  • Adherence to standard of care for hereditary breast and ovarian cancer (HBOC) and Lynch syndromesUp to 5 years

    For Lynch syndrome we identify compliance as colonoscopy in past two years and bilateral salpingo-oophorectomy (BSO ) after child-bearing age. For HBOC, compliance is defined as breast imaging in past year or risk reducing surgery at any point in women.

  • Merged risk reduction strategies of bilateral salpingo-oophorectomy (BSO) or bilateral mastectomy and imagingUp to 5 years

    The merged risk reduction strategies of BSO or bilateral mastectomy and the imaging are treated as evidence of risk reducing behavior.

  • Cascade screening rate among Lynch or HBOC positive carriersUp to 5 years

    Will conduct negative binomial regression model and non-inferiority will be determined by rate ratio and its 95% confidence interval (CI).