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

NCT03291106 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2018-11-14

No results posted yet for this study

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.

Conditions

  • Colorectal Neoplasms, Hereditary Nonpolyposis
  • Endometrial Neoplasms

Interventions

DIAGNOSTIC_TEST

immunohistochemical staining

immunohistochemical staining for MLH1, MSH2, MSH6 and PMS2

DIAGNOSTIC_TEST

tests of microsatellite instability

microsatellite instability in tissues of endometrial cancer

DIAGNOSTIC_TEST

clinical criteria of Lynch syndromes

Amsterdam I or II criteria and Bethesda criteria

DIAGNOSTIC_TEST

sequencing for mismatch repair genes

next-generation sequencing, Sanger method or qPCR for mismatch repair genes (MLH1, MSH2, MSH6, PMS2, and EPCAM)

Sponsors & Collaborators

  • Lei Li

    lead OTHER

Principal Investigators

  • Lei Li, MD · Peking Union Medical College Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2019-10-01
Completion
2020-10-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03291106 on ClinicalTrials.gov