Skip to main content
OpenTrials
Completed

NCT Number: NCT03460483

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endometrial Adenocarcinoma Colonic Diseases Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders Digestive System Diseases Digestive System Neoplasms Endometrial Carcinoma Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Intestinal Diseases Intestinal Neoplasms Lynch Syndrome Metabolic Diseases Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Nutritional and Metabolic Diseases Relatives Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Summa Akron City Hospital/Cooper Cancer Center, Akron, Ohio, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genetic Counseling

Other

Undergo genetic counseling

Genetic Testing

Other

Undergo genetic testing

Other names: genetic analysis, Genetic Examination, Genetic Test

laboratory biomarker analysis

Other

Correlative studies

Mutation Carrier Screening

Procedure

Undergo tumor screening via next-generation sequencing

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Ohio Prevention and Treatment of Endometrial Cancer (OPTEC) Initiative: Universal Screening for DNA Mismatch Repair Deficiency and Personalized Cancer Treatment

Acronym: OPTEC

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Mar 9, 2018
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.