Identifying and Caring for Individuals With Inherited Cancer Syndrome

Last updated: April 3, 2025
Sponsor: OHSU Knight Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Breast Cancer

Colon Cancer

Treatment

Genetic Testing

Biospecimen Collection

Genetic Counseling

Clinical Study ID

NCT04494945
STUDY00020629
U01CA232819
STUDY00020629
NCI-2020-04627
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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

Study Design

Total Participants: 27500
Treatment Group(s): 4
Primary Treatment: Genetic Testing
Phase:
Study Start date:
March 09, 2020
Estimated Completion Date:
June 10, 2030

Study 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:

I. Measure adherence to current guidelines for screening and prophylactic intervention of Cohorts B and C compared to Cohort A to show non-inferiority.

II. Measure the efficiency of cascade testing (defined as the ratio of family members screened over total possible) for Cohorts B and C compared to Cohort A to show non-inferiority.

III. 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.

OUTLINE:

Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling. Patients also complete a survey about cancer prevention, screening, and treatment.

Connect with a study center

  • OHSU Knight Cancer Institute

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Active - Recruiting

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