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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03460483
Recruitment Status : Active, not recruiting
First Posted : March 9, 2018
Last Update Posted : September 9, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paul Goodfellow, Ohio State University Comprehensive Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Endometrial Adenocarcinoma Endometrial Carcinoma Lynch Syndrome Relatives Other: Genetic Counseling Other: Genetic Testing Other: Laboratory Biomarker Analysis Procedure: Mutation Carrier Screening Not Applicable

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.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1002 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Ohio Prevention and Treatment of Endometrial Cancer (OPTEC) Initiative: Universal Screening for DNA Mismatch Repair Deficiency and Personalized Cancer Treatment
Actual Study Start Date : March 30, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Arms and Interventions
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Arm Intervention/treatment
Experimental: Comprehensive LS genetic testing
Testing for inherited forms of cancer and tumor sequencing
 Other: Genetic Counseling
Undergo genetic counseling

Other: Genetic Testing
Undergo genetic testing
Other Names:
  • genetic analysis
  • Genetic Examination
  • Genetic Test

Other: Laboratory Biomarker Analysis
Correlative studies

Procedure: Mutation Carrier Screening
Undergo tumor screening via next-generation sequencing


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460483


Locations
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United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Aultman Health Foundation
Canton, Ohio, United States, 44710
University of Cincinnati
Cincinnati, Ohio, United States, 45219
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, United States, 45245
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Ohio Health
Columbus, Ohio, United States, 43214
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, United States, 43608
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Paul Goodfellow Ohio State University Comprehensive Cancer Center
More Information
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Additional Information:

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Responsible Party: Paul Goodfellow, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03460483    
Other Study ID Numbers: OSU-17149
NCI-2018-00218 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA016058 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Syndrome
Neoplastic Syndromes, Hereditary
Colorectal Neoplasms, Hereditary Nonpolyposis
Disease
Pathologic Processes
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
 Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases