Identifying and Caring for Individuals With Inherited Cancer Syndrome

Overview

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.

Full Title of Study: “Approaches to Identify and Care for Individuals With Inherited Cancer Syndromes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 10, 2025

Detailed 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.

Interventions

  • Procedure: Biospecimen Collection
    • Undergo collection of saliva sample
  • Other: Genetic Counseling
    • Receive genetic counseling if testing results are positive
  • Other: Genetic Testing
    • Undergo genetic testing

Arms, Groups and Cohorts

  • Other: Screening (genetic testing)
    • Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.

Clinical Trial Outcome Measures

Primary Measures

  • Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations
    • Time Frame: Up 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 syndromes
    • Time Frame: Up 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 imaging
    • Time Frame: Up 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 carriers
    • Time Frame: Up to 5 years
    • Will conduct negative binomial regression model and non-inferiority will be determined by rate ratio and its 95% confidence interval (CI).

Participating in This Clinical Trial

Inclusion Criteria

  • Consent to this project, either hard or electronic signature
  • Creation of secure Medable account
  • Electronically signed Healthy Oregon Project (HOP) consent form (found within Medable app)
  • Choosing to submit a deoxyribonucleic acid (DNA) sample

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • OHSU Knight Cancer Institute
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Paul T Spellman, Ph.D., Principal Investigator – OHSU Knight Cancer Institute
  • Overall Official(s)
    • Paul T Spellman, Ph.D., Principal Investigator, OHSU Knight Cancer Institute

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