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MSI in Circulatory DNA of Endometrial Cancer

Sponsor
Lei Li (Other)
Overall Status
Unknown status
CT.gov ID
NCT03744962
Collaborator
(none)
100
Enrollment
1
Location
25.4
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to analyze the microsatellite instability (MSI) in the circulatory tumor DNA and in the tumor tissue in the patients diagnosed with uterine endometrial cancer. These data will be used for the study of "Cohort Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer" (NCT03291106, clinicaltrials.gov).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Compare of Microsatellite Instability in Circulatory DNA and Tumor Tissue of Endometrial Cancer
    Actual Study Start Date :
    Nov 10, 2018
    Anticipated Primary Completion Date :
    Dec 23, 2020
    Anticipated Study Completion Date :
    Dec 23, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Frequency of microsatellite instability [Two years]

      Frequencies of different status of microsatellite instability (high microsatellite instability or microsatellite-stable) in the circulatory tumor DNA and in the tumor tissue

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Confirmed primary endometrial cancer before any surgical or chemotherapy treatment

    • Signed an approved informed consents

    • Feasible for sampling

    Exclusion Criteria:
    • Not meeting all of the inclusion criteria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lei Li Beijing Beijing China 100730

    Sponsors and Collaborators

    • Lei Li

    Investigators

    • Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lei Li, Professor, Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT03744962
    Other Study ID Numbers:
    • EC-MSI
    First Posted:
    Nov 19, 2018
    Last Update Posted:
    Nov 19, 2018
    Last Verified:
    Nov 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Endometrial Neoplasms
    Neoplastic Cells, Circulating
    Colorectal Neoplasms, Hereditary Nonpolyposis
    Microsatellite Instability

    Study Results

    No Results Posted as of Nov 19, 2018