NCT03291106

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

2.1 years

First QC Date

September 20, 2017

Last Update Submit

November 9, 2018

Conditions

Colorectal Neoplasms, Hereditary NonpolyposisEndometrial Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Distribution of Lynch syndromes in endometrial cancer

    Proportions of patients carrying mismatch repair gene in endometrial cancer

    2 years

Secondary Outcomes (3)

  • Reliability of immunohistochemical staining for screening Lynch syndromes

    2 years

  • Reliability of microsatellite instability for screening Lynch syndromes

    2 years

  • Reliability of clinical criteria for screening Lynch syndromes

    2 years

Interventions

immunohistochemical stainingDIAGNOSTIC_TEST

immunohistochemical staining for MLH1, MSH2, MSH6 and PMS2

tests of microsatellite instabilityDIAGNOSTIC_TEST

microsatellite instability in tissues of endometrial cancer

clinical criteria of Lynch syndromesDIAGNOSTIC_TEST

Amsterdam I or II criteria and Bethesda criteria

sequencing for mismatch repair genesDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Survivals of endometrial cancer

You may not qualify if:

  • Metatatic malignacies to uterine
  • Leiomyosarcoma of uterus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lei Li

Beijing, China/Beiing, 100000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31307542DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary NonpolyposisEndometrial Neoplasms

Interventions

Base Sequence

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsNeoplastic Syndromes, HereditaryDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Molecular StructureBiochemical PhenomenaChemical PhenomenaGenetic StructuresGenetic Phenomena

Study Officials

  • Lei Li, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, MD

CONTACT

13911988831lileigh@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 25, 2017

Study Start

September 1, 2017

Primary Completion

October 1, 2019

Study Completion

October 1, 2020

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

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

Shared Documents
CSR

Locations

CN(1)