Identifying and Caring for Individuals With Inherited Cancer Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

27500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-09

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Screening (genetic testing)

Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.

Group Type OTHER

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of saliva sample

Genetic Counseling

Intervention Type OTHER

Receive genetic counseling if testing results are positive

Genetic Testing

Intervention Type OTHER

Undergo genetic testing

Survey Administration

Intervention Type OTHER

Complete a survey

Interventions

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Biospecimen Collection

Undergo collection of saliva sample

Intervention Type PROCEDURE

Genetic Counseling

Receive genetic counseling if testing results are positive

Intervention Type OTHER

Genetic Testing

Undergo genetic testing

Intervention Type OTHER

Survey Administration

Complete a survey

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection genetic analysis Genetic Examination Genetic Test

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes