Identifying and Caring for Individuals With Inherited Cancer Syndrome

March 8, 2024 updated by: Jackie Shannon, OHSU Knight Cancer Institute

Approaches to Identify and Care for Individuals With Inherited Cancer Syndromes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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. Patients also complete a survey about cancer prevention, screening, and treatment.

Study Type

Interventional

Enrollment (Estimated)

27500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
        • Principal Investigator:
          • Bill J. Wright, Ph.D.
      • Portland, Oregon, United States, 97239
        • Recruiting
        • OHSU Knight Cancer Institute
        • Contact:
        • Principal Investigator:
          • Jackilen Shannon, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Screening (genetic testing)
Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.
Other: Genetic Testing
Undergo genetic testing
Other Names:
  • genetic analysis
  • Genetic Examination
  • Genetic Test
Other: Survey Administration
Complete a survey
Procedure: Biospecimen Collection
Undergo collection of saliva sample
Other Names:
  • Biological Sample Collection
Other: Genetic Counseling
Receive genetic counseling if testing results are positive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years
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.
Up to 5 years
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.
Up to 5 years
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).
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OHSU Knight Cancer Institute

Collaborators

National Cancer Institute (NCI)
Oregon Health and Science University

Investigators

  • Principal Investigator: Jackilen Shannon, Ph.D., OHSU Knight Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2020

Primary Completion (Estimated)

June 10, 2025

Study Completion (Estimated)

June 10, 2030

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

July 31, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00020629 (Other Identifier: OHSU Knight Cancer Institute)
  • NCI-2020-04627 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U01CA232819 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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