Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer

November 9, 2018 updated by: Lei Li

Cohort Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer

In patients diagnosed as endometrial cancer by thorough pathologic examinations, Lynch syndromes are screened by (1)immunohistochemical staining (for MLH1, MSH2, MSH6 and PMS2), (2) tests of microsatellite instability and (3) clinical criteria (Amsterdam I or II criteria and Bethesda criteria). For patients with any suspicious discoveries of Lynch syndromes from aforementioned screening methods, a molecular diagnosis with next-generation sequencing for mismatch repair genes (MLH1, MSH2, MSH6, PMS2, and EPCAM) is given to confirm Lynch syndromes. For patients of Lynch syndromes and endometrial cancer, relatives of blood lineage are tested by Sanger method or qPCR to find out carriers of mutation genes of Lynch syndromes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • China/Beiing
      • Beijing, China/Beiing, China, 100000
        • Recruiting
        • Lei Li
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patiens with definite diagnosis of endometrial cancer, including type I and type II endometrial cancer.

Description

Inclusion Criteria:

  • Survivals of endometrial cancer

Exclusion Criteria:

  • Metatatic malignacies to uterine
  • Leiomyosarcoma of uterus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of Lynch syndromes in endometrial cancer
Time Frame: 2 years
Proportions of patients carrying mismatch repair gene in endometrial cancer
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliability of immunohistochemical staining for screening Lynch syndromes
Time Frame: 2 years
Sensitiviy and specitiviy of immunohistochemical staining for screening Lynch syndromes
2 years
Reliability of microsatellite instability for screening Lynch syndromes
Time Frame: 2 years
Sensitiviy and specitiviy of microsatellite instability for screening Lynch syndromes
2 years
Reliability of clinical criteria for screening Lynch syndromes
Time Frame: 2 years
Sensitiviy and specitiviy of clinical criteria for screening Lynch syndromes
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lei Li

Investigators

  • Principal Investigator: Lei Li, MD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

September 20, 2017

First Submitted That Met QC Criteria

September 21, 2017

First Posted (Actual)

September 25, 2017

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 9, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC-LYNCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Distributions of specific mutation genes of Lynch syndromes will be available for other researches by officially published papers.

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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