Universal Endometrial Cancer DNA Sequencing for Detection of Lynch Syndrome and Personalized Care

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

COMPLETED

Clinical Phase

NA

Total Enrollment

1001 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-30

Study Completion Date

2025-06-15

Brief Summary

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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.

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Detailed Description

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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.

V. Identify molecular signatures that may be associated with favorable response to specific treatments (including chemotherapeutic agents, non-surgical options, and novel clinical trials \[in particular, patients with mismatch repair (MMR)-deficient or POLE-mutant tumors\]).

VI. Determine if recurrence likelihood can be predicted from molecular signature.

VII. Identify EC patients with select molecular signatures for recruitment to long-term follow-up, cancer prevention, and treatment studies.

OUTLINE:

Patients with endometrial cancer undergo clinical testing for inherited cancer mutations using blood DNA and via next-generation sequencing of tumor samples. Patients testing positive for Lynch syndrome or other cancer susceptibilities will undergo genetic counseling and testing and counseling will be offered to their family members.

Conditions

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Endometrial Adenocarcinoma Endometrial Carcinoma Lynch Syndrome Relatives

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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Comprehensive LS genetic testing

Testing for inherited forms of cancer and tumor sequencing

Group Type EXPERIMENTAL

Genetic Counseling

Intervention Type OTHER

Undergo genetic counseling

Genetic Testing

Intervention Type OTHER

Undergo genetic testing

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Mutation Carrier Screening

Intervention Type PROCEDURE

Undergo tumor screening via next-generation sequencing

Interventions

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Genetic Counseling

Undergo genetic counseling

Intervention Type OTHER

Genetic Testing

Undergo genetic testing

Intervention Type OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Mutation Carrier Screening

Undergo tumor screening via next-generation sequencing

Intervention Type PROCEDURE

Other Intervention Names

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genetic analysis Genetic Examination Genetic Test

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes