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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03338985
Other study ID # PA17002
Secondary ID
Status Recruiting
Phase N/A
First received November 8, 2017
Last updated January 4, 2018
Start date October 16, 2017
Est. completion date April 16, 2020

Study information

Verified date January 2018
Source CHU de Reims
Contact Emilie RAIMOND
Phone 0326789598
Email eraimond@chu-reims.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Several molecular studies showed chromosomal alterations in patients with endometrial cancer, with gains in 1q, 19p, 19q, 8q, 10q and 10p and loss of 4q, 16q and 18q. Several genes of interest have been identified (P53, PTEN, PIK3CA, ß-catenin, K-ras ...).

A study has already been carried out at the Reims University Hospital with inclusion of patients with endometrial cancer and patients with endometrial hyperplasia. It identified specific alterations of nosologic continuum of pathology and characterize areas of interest on the genome.


Description:

make a pangenomic investigation of genetic abnormalities in atypical endometrial hyperplasia and endometrial cancers.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date April 16, 2020
Est. primary completion date October 16, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patient with endometrial hyperplasia or endometrial cancer

- patient consenting to participate to the study

- patient enrolled in the national healthcare insurance program

- patient older than 18 years

Exclusion Criteria:

- patient with neoadjuvant chemotherapy or radiotherapy prior to surgery

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
Genetic analysis
Genetic analysis of the samples taken during the surgery (hysterectomy or curettage resection) using CGH array technique.

Locations

Country Name City State
France Damien JOLLY Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Genetic imbalances Genetic aberrations detected by comparative genomic hybridization (CGH arry) Day 0