MSI in Circulatory DNA of Endometrial Cancer

NCT03744962 | Unknown DMC

• 1 other identifier: EC-MSI
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Microsatellite Instability; Lynch Syndrome; Endometrial Cancer; Circulating Tumor Cell

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

An 8 ml peripheral venous blood, and 50 μL cancer tissue or tissue from from paraffin section will be collected from eligible patients.

MeSH Terms

Conditions

Microsatellite Instability; Colorectal Neoplasms, Hereditary Nonpolyposis; Endometrial Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Genomic Instability; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasm Metastasis; Neoplastic Processes

Study Officials

• Lei Li, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

13911988831; lileigh@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: November 9, 2018
• First Posted: November 19, 2018
• Study Start: November 10, 2018
• Primary Completion: December 23, 2020
• Study Completion: December 23, 2020
• Last Updated: November 19, 2018

Record last verified: 2018-11

Locations

CN (1)