Identifying and Caring for Individuals With Inherited Cancer Syndrome

Not Applicable

Recruiting

• Conditions: Hematopoietic and Lymphoid System Neoplasm; Breast Ductal Carcinoma In Situ; BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome; Lynch Syndrome; Hereditary Neoplastic Syndrome; Malignant Solid Neoplasm
• Interventions: Procedure: Biospecimen Collection; Other: Genetic Counseling; Other: Genetic Testing; Other: Survey Administration

• Registration Number: NCT04494945
• Lead Sponsor: OHSU Knight Cancer Institute

Brief 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.

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 Timeline

• Study Start: 2020-03-09
• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31
• Primary Completion: 2025-06-10
• Study Completion: 2030-06-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27500

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening (genetic testing)	Biospecimen Collection	Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.
Screening (genetic testing)	Genetic Counseling	Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.
Screening (genetic testing)	Survey Administration	Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.
Screening (genetic testing)	Genetic Testing	Patients undergo collection of saliva samples for genetic testing. If genetic test is positive, patients receive genetic counseling.

Primary Outcome Measures

Name	Time	Method
Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations	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.
Cascade screening rate among Lynch or HBOC positive carriers	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).
Adherence to standard of care for hereditary breast and ovarian cancer (HBOC) and Lynch syndromes	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	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.

Trial Locations

Locations (2)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States

Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States