- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03744962
MSI in Circulatory DNA of Endometrial Cancer
November 15, 2018 updated by: Lei Li
A Compare of Microsatellite Instability in Circulatory DNA and Tumor Tissue of Endometrial Cancer
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).
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Lei Li
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Patients confirmed primary endometrial cancer before any surgical or chemotherapy treatment will be all included.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of microsatellite instability
Time Frame: Two years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 10, 2018
Primary Completion (Anticipated)
December 23, 2020
Study Completion (Anticipated)
December 23, 2020
Study Registration Dates
First Submitted
November 9, 2018
First Submitted That Met QC Criteria
November 15, 2018
First Posted (Actual)
November 19, 2018
Study Record Updates
Last Update Posted (Actual)
November 19, 2018
Last Update Submitted That Met QC Criteria
November 15, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Metabolic Diseases
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genetic Diseases, Inborn
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Neoplastic Processes
- Colorectal Neoplasms
- Neoplastic Syndromes, Hereditary
- DNA Repair-Deficiency Disorders
- Neoplasm Metastasis
- Genomic Instability
- Colorectal Neoplasms, Hereditary Nonpolyposis
- Endometrial Neoplasms
- Microsatellite Instability
- Neoplastic Cells, Circulating
Other Study ID Numbers
- EC-MSI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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