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

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03460483
Collaborator
National Cancer Institute (NCI) (NIH)
1,002
Enrollment
9
Locations
1
Arm
51
Anticipated Duration (Months)
111.3
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Genetic Counseling
  • Other: Genetic Testing
  • Other: Laboratory Biomarker Analysis
  • Procedure: Mutation Carrier Screening
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. Molecular classification of tumor abnormalities through innovative upfront next-generation DNA sequencing.

  2. Identify endometrial cancer (EC) patients with inherited EC, specifically Lynch syndrome (LS), using both tumor and normal (blood) DNA testing.

  3. Develop a comprehensive approach to genetic risk assessment and management including improved cascade testing in at-risk relatives.

  4. Provide local access to genetic counseling for patients with harmful germline mutations.

  5. 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]).

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

  7. 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

Study Type:
Interventional
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 :
Mar 30, 2018
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

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

    Primary Outcome Measures

    1. Incidence of endometrial cancer patients with Lynch syndrome [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 [Up to 3 years]

      Measured by molecular profiling of tumor DNA via next-generation sequencing.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Summa Akron City Hospital/Cooper Cancer Center Akron Ohio United States 44304
    2 Aultman Health Foundation Canton Ohio United States 44710
    3 University of Cincinnati Cincinnati Ohio United States 45219
    4 TriHealth Cancer Institute-Westside Cincinnati Ohio United States 45245
    5 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    6 MetroHealth Medical Center Cleveland Ohio United States 44109
    7 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    8 Ohio Health Columbus Ohio United States 43214
    9 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

    • Principal Investigator: Paul Goodfellow, Ohio State University Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    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
    • P30CA016058
    First Posted:
    Mar 9, 2018
    Last Update Posted:
    Sep 9, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Endometrial Neoplasms
    Colorectal Neoplasms, Hereditary Nonpolyposis
    Syndrome

    Study Results

    No Results Posted as of Sep 9, 2021