MSI in Circulatory DNA of Endometrial Cancer | NCT03744962

Studies
MSI in Circulatory DNA of Endometrial Cancer

NCT03744962

Sponsor

Lei Li

Status

Unknown status

Last Update Posted

Nov 19, 2018Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Microsatellite Instability
Lynch Syndrome
Endometrial Cancer
Circulating Tumor Cell

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2018Actual

Primary Completion Date

Dec 23, 2020Estimated

Completion Date

Dec 23, 2020Estimated

First Submitted Date

Nov 9, 2018

First Submission Date that Met QC Criteria

Nov 15, 2018

First Posted Date

Nov 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2018

Last Update Posted Date

Nov 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to analyze the microsatellite instability (MSI) in the circulatory tumor DNA and in the tumor tissue in the patients diagnosed with uterine endometrial cancer. These data will be used for the study of "Cohort Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer" (NCT03291106, clinicaltrials.gov).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of microsatellite instability	Frequencies of different status of microsatellite instability (high microsatellite instability or microsatellite-stable) in the circulatory tumor DNA and in the tumor tissue	Two years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed primary endometrial cancer before any surgical or chemotherapy treatment
Signed an approved informed consents
Feasible for sampling

Exclusion Criteria:

Not meeting all of the inclusion criteria

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients confirmed primary endometrial cancer before any surgical or chemotherapy treatment will be all included.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lei Li, M.D.	Contact	13911988831	86	lileigh@163.com

Overall Officials

Name	Affiliation	Role
Lei Li, M.D.	Peking Union Medical College Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lei Li	Recruiting	Beijing	Beijing Municipality	100730	China

Condition Browse Module

MeSH Terms

ID	Term
D053842	Microsatellite Instability
D003123	Colorectal Neoplasms, Hereditary Nonpolyposis
D016889	Endometrial Neoplasms
D009360	Neoplastic Cells, Circulating

Ancestor Terms

ID	Term
D042822	Genomic Instability
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D015179	Colorectal Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided