Ohio Prevention and Treatment of Endometrial Cancer (OPTEC) Initiative: Universal Screening for DNA Mismatch Repair Deficiency and Personalized Cancer Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,001
- Locations
- 18
- Primary Endpoint
- Incidence of endometrial cancer patients with Lynch syndrome
Study Overview
Brief Summary
This clinical trial studies universal screening for deoxyribonucleic acid (DNA) mismatch repair deficiency in patients with endometrial cancer, mutations in the genes responsible for Lynch syndrome (inherited forms of endometrial cancers) and other DNA changes that could help guide treatment strategies. Universal tumor DNA sequencing may help doctors better understand how to personalize care, increase length of life, and increase quality of life in patients with endometrial cancer and their relatives.
Detailed Description
PRIMARY OBJECTIVES:
I. Molecular classification of tumor abnormalities through innovative upfront next-generation DNA sequencing.
II. Identify endometrial cancer (EC) patients with inherited EC, specifically Lynch syndrome (LS), using both tumor and normal (blood) DNA testing.
III. Develop a comprehensive approach to genetic risk assessment and management including improved cascade testing in at-risk relatives.
IV. Provide local access to genetic counseling for patients with harmful germline mutations.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult women who had a hysterectomy or diagnostic biopsy proving endometrial adenocarcinoma (any stage) between 10/1/2017 and 4/30/2020, and received care at one of the participating hospitals
- •Adult relatives of the EC patients found to have LS
Exclusion Criteria
- •Individuals must be able to speak and read English; non-English speaking individuals will be excluded
- •Individuals must be able to consent for themselves; those who are unable to consent for themselves for any reason will be excluded
- •Prisoners will be specifically excluded from participation in the study
- •Women who have uterine sarcomas are excluded
- •Pregnant women are not eligible for the study
Arms & Interventions
Comprehensive LS genetic testing
Testing for inherited forms of cancer and tumor sequencing
Intervention: Genetic Counseling (Other)
Comprehensive LS genetic testing
Testing for inherited forms of cancer and tumor sequencing
Intervention: Genetic Testing (Other)
Comprehensive LS genetic testing
Testing for inherited forms of cancer and tumor sequencing
Intervention: Laboratory Biomarker Analysis (Other)
Comprehensive LS genetic testing
Testing for inherited forms of cancer and tumor sequencing
Intervention: Mutation Carrier Screening (Procedure)
Outcomes
Primary Outcomes
Incidence of endometrial cancer patients with Lynch syndrome
Time Frame: Up to 3 years
Measured by molecular profiling of tumor deoxyribonucleic acid (DNA) via next-generation sequencing.
Incidence of tumors with microsatellite instability and/or somatic POLE mutations
Time Frame: Up to 3 years
Measured by molecular profiling of tumor DNA via next-generation sequencing.
Secondary Outcomes
No secondary outcomes reported
Investigators
Paul Goodfellow
Principal Investigator
Ohio State University Comprehensive Cancer Center