Clinical Trials /

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

NCT03460483

Description:

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.

Related Conditions:
  • Endometrial Adenocarcinoma
Recruiting Status:

Suspended

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Universal Endometrial Cancer DNA Sequencing for Detection of Lynch Syndrome and Personalized Care
  • Official Title: Ohio Prevention and Treatment of Endometrial Cancer (OPTEC) Initiative: Universal Screening for DNA Mismatch Repair Deficiency and Personalized Cancer Treatment

Clinical Trial IDs

  • ORG STUDY ID: OSU-17149
  • SECONDARY ID: NCI-2018-00218
  • SECONDARY ID: P30CA016058
  • NCT ID: NCT03460483

Conditions

  • Endometrial Adenocarcinoma
  • Endometrial Carcinoma
  • Lynch Syndrome
  • Relatives

Purpose

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.

      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.
    

Trial Arms

NameTypeDescriptionInterventions
Comprehensive LS genetic testingExperimentalTesting for inherited forms of cancer and tumor sequencing

    Eligibility 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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:Accepts Healthy Volunteers

    Primary Outcome Measures

    Measure:Incidence of endometrial cancer patients with Lynch syndrome
    Time Frame:Up to 3 years
    Safety Issue:
    Description:Measured by molecular profiling of tumor deoxyribonucleic acid (DNA) via next-generation sequencing.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Suspended
    Lead Sponsor:Ohio State University Comprehensive Cancer Center

    Last Updated

    April 2, 2020