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NCT03291106 Clinical Trial

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

Endometrial Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03291106
Other study ID # EC-LYNCH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date October 1, 2020

Study information
Verified date November 2018
Source Peking Union Medical College Hospital
Contact Lei Li, MD
Phone 13911988831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1500
Est. completion date October 1, 2020
Est. primary completion date October 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Survivals of endometrial cancer

Exclusion Criteria:

- Metatatic malignacies to uterine

- Leiomyosarcoma of uterus

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• immunohistochemical staining
immunohistochemical staining for MLH1, MSH2, MSH6 and PMS2
• tests of microsatellite instability
microsatellite instability in tissues of endometrial cancer
• clinical criteria of Lynch syndromes
Amsterdam I or II criteria and Bethesda criteria
• sequencing for mismatch repair genes
next-generation sequencing, Sanger method or qPCR for mismatch repair genes (MLH1, MSH2, MSH6, PMS2, and EPCAM)

Locations
Country Name City State
China Lei Li Beijing China/Beiing

Sponsors (1)
Lead Sponsor Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Distribution of Lynch syndromes in endometrial cancer Proportions of patients carrying mismatch repair gene in endometrial cancer 2 years
Secondary Reliability of immunohistochemical staining for screening Lynch syndromes Sensitiviy and specitiviy of immunohistochemical staining for screening Lynch syndromes 2 years
Secondary Reliability of microsatellite instability for screening Lynch syndromes Sensitiviy and specitiviy of microsatellite instability for screening Lynch syndromes 2 years
Secondary Reliability of clinical criteria for screening Lynch syndromes Sensitiviy and specitiviy of clinical criteria for screening Lynch syndromes 2 years
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