Identifying and Caring for Individuals With Inherited Cancer Syndrome

  • STATUS
    Recruiting
  • End date
    Jun 10, 2030
  • participants needed
    27500
  • sponsor
    OHSU Knight Cancer Institute
Updated on 23 March 2022
cancer
carcinoma
breast cancer
carcinoma in situ
primary cancer
BRCA1
BRCA2
genetic testing
ductal carcinoma in situ
ductal carcinoma
cancer of the ovary
Accepts healthy volunteers

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.

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.

Details
Condition 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
Treatment genetic testing, Genetic Counseling, survey administration, biospecimen collection
Clinical Study IdentifierNCT04494945
SponsorOHSU Knight Cancer Institute
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

ALL COHORTS: 18 years of age or older
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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