Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID04494945

Approaches to Identify and Care for Individuals With Inherited Cancer Syndromes

Led by OHSU Knight Cancer Institute · Updated on 2026-01-23

27500

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

O

OHSU Knight Cancer Institute

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating ways to identify and care for individuals with inherited cancer syndromes, such as hereditary breast and ovarian cancer and Lynch syndromes. The study aims to assess the value of offering broad genetic testing to the public at no cost, rather than limiting testing to those with known high-risk family histories. It also compares the effectiveness and sustainability of heritable cancer syndrome testing in two new screening populations against current guidelines. Participants provide saliva samples for genetic testing. If the test results are positive, they receive genetic counseling. Additionally, participants complete surveys about cancer prevention, screening, and treatment. The study includes multiple cohorts, some retrospective and others enrolling new participants via a secure app, with follow-up to assess adherence to guidelines and cost-effectiveness of the screening models. During the study, researchers monitor outcomes such as effectiveness and sustainability of testing, adherence to recommended cancer screening and prevention strategies, and family cascade screening rates over up to five years. Participants are involved in genetic testing, counseling if needed, and survey completion. The research team collects data to evaluate quality-adjusted life years and cost-effectiveness of the genetic screening approaches.

CONDITIONS

Brief Title

Identifying and Caring for Individuals With Inherited Cancer Syndrome

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • 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: Patients have received genetic counseling in the past 1 to 2 years
  • Cohort A: Patients have genetic variants that include BRCA1, BRCA2, and/or Lynch syndrome
  • Cohort B: Creation of a secure Healthy Oregon Project (HOP) app account
  • Cohort B: Consent to this project and the HOP repository
  • Cohort B: Choosing to submit a DNA sample
  • Cohort B: Patients diagnosed with any National Cancer Institute-reportable cancers, including ductal carcinoma in situ or in situ breast cancer
  • Cohort B: Must have had a healthcare encounter within the past 12 months
  • Cohort C: Creation of a secure HOP app account
  • Cohort C: Consent to this project and the HOP repository
  • Cohort C: Choosing to submit a DNA sample
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Up to 5 years

Participants undergo genetic testing using saliva samples to identify heritable cancer syndromes. Those with positive results receive genetic counseling and complete a survey about cancer prevention, screening, and treatment.

1 visit for sample collection and survey; additional visits for genetic counseling if testing is positive

Trial Site Locations

Total: 2 locations

1

Providence Portland Medical Center

Portland, Oregon, United States, 97213

Actively Recruiting

2

OHSU Knight Cancer Institute

Portland, Oregon, United States, 97239

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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