Identifying and Caring for Individuals With Inherited Cancer Syndrome

OHSU Knight Cancer Institute

Status

Enrolling

Conditions

Lynch Syndrome

Breast Ductal Carcinoma In Situ

Malignant Solid Neoplasm

Hereditary Neoplastic Syndrome

Hematopoietic and Lymphoid System Neoplasm

BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome

Treatments

Other: Genetic Counseling

Procedure: Biospecimen Collection

Other: Genetic Testing

Other: Survey Administration

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04494945

NCI-2020-04627 (Registry Identifier)

U01CA232819 (U.S. NIH Grant/Contract)

STUDY00020629 (Other Identifier)

Details and patient eligibility

About

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 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.

Enrollment

27,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 Healthy Oregon Project (HOP) app account
COHORT B: Consent to this project, either hard or electronic signature
COHORT B: Consent to the 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 Hop app 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