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

NCT ID: NCT03291106

Last Updated: 2018-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-10-01

Brief Summary

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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

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Conditions

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Colorectal Neoplasms, Hereditary Nonpolyposis Endometrial Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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immunohistochemical staining

immunohistochemical staining for MLH1, MSH2, MSH6 and PMS2

Intervention Type DIAGNOSTIC_TEST

tests of microsatellite instability

microsatellite instability in tissues of endometrial cancer

Intervention Type DIAGNOSTIC_TEST

clinical criteria of Lynch syndromes

Amsterdam I or II criteria and Bethesda criteria

Intervention Type DIAGNOSTIC_TEST

sequencing for mismatch repair genes

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Survivals of endometrial cancer

Exclusion Criteria

* Metatatic malignacies to uterine
* Leiomyosarcoma of uterus
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lei Li

OTHER

Sponsor Role lead

Responsible Party

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Lei Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lei Li, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Lei Li

Beijing, China/Beiing, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Li, MD

Role: CONTACT

13911988831 ext. +86

Facility Contacts

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Lei L Li, MD

Role: primary

13911988831 ext. +86

References

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Chao X, Li L, Wu M, Ma S, Tan X, Zhong S, Bi Y, Lang J. Comparison of screening strategies for Lynch syndrome in patients with newly diagnosed endometrial cancer: a prospective cohort study in China. Cancer Commun (Lond). 2019 Jul 15;39(1):42. doi: 10.1186/s40880-019-0388-2.

Reference Type DERIVED
PMID: 31307542 (View on PubMed)

Other Identifiers

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EC-LYNCH

Identifier Type: -

Identifier Source: org_study_id

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