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

• Conditions: Colorectal Neoplasms, Hereditary Nonpolyposis; Endometrial Neoplasms

• Registration Number: NCT03291106
• Lead Sponsor: Lei Li

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-21
• Study First Posted: 2017-09-25
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-09
• Last Update Posted: 2018-11-14
• Primary Completion: 2019-10-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1500

Inclusion Criteria

• Survivals of endometrial cancer

Exclusion Criteria

• Metatatic malignacies to uterine
• Leiomyosarcoma of uterus

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distribution of Lynch syndromes in endometrial cancer	2 years	Proportions of patients carrying mismatch repair gene in endometrial cancer

Secondary Outcome Measures

Name	Time	Method
Reliability of immunohistochemical staining for screening Lynch syndromes	2 years	Sensitiviy and specitiviy of immunohistochemical staining for screening Lynch syndromes
Reliability of microsatellite instability for screening Lynch syndromes	2 years	Sensitiviy and specitiviy of microsatellite instability for screening Lynch syndromes
Reliability of clinical criteria for screening Lynch syndromes	2 years	Sensitiviy and specitiviy of clinical criteria for screening Lynch syndromes

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, China/Beiing, China