Identifying and Caring for Individuals With Inherited Cancer Syndrome

Malignant Solid Neoplasm Clinical Trial

Official title:

Approaches to Identify and Care for Individuals With Inherited Cancer Syndromes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04494945
• Other study ID #: STUDY00020629
• Secondary ID: NCI-2020-04627ST
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2020
• Est. completion date: June 10, 2030

Study information

• Verified date: March 2024
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27500
• Est. completion date: June 10, 2030
• Est. primary completion date: June 10, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Ductal Carcinoma In Situ
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Hematopoietic and Lymphoid System Neoplasm
• Hereditary Breast and Ovarian Cancer Syndrome
• Hereditary Neoplastic Syndrome
• Lynch Syndrome
• Malignant Solid Neoplasm
• Neoplasms
• Neoplastic Syndromes, Hereditary
• Syndrome

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of saliva sample

Other:
• Genetic Counseling
Receive genetic counseling if testing results are positive
• Genetic Testing
Undergo genetic testing
• Survey Administration
Complete a survey

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon
United States	Providence Portland Medical Center	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI), Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness and sustainability of heritable cancer syndrome testing in the two novel testing populations	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
Primary	Adherence to standard of care for hereditary breast and ovarian cancer (HBOC) and Lynch syndromes	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
Primary	Merged risk reduction strategies of bilateral salpingo-oophorectomy (BSO) or bilateral mastectomy and imaging	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
Primary	Cascade screening rate among Lynch or HBOC positive carriers	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