Role of Senescence in the Development of Endometrial Cancer

January 4, 2018 updated by: CHU de Reims

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group "cases patients"
patients with endometrial hyperplasia or endometrial cancers
Genetic: Genetic analysis
Genetic analysis of the samples taken during the surgery (hysterectomy or curettage resection) using CGH array technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic imbalances
Time Frame: Day 0
Genetic aberrations detected by comparative genomic hybridization (CGH arry)
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

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)

October 16, 2017

Primary Completion (Anticipated)

October 16, 2019

Study Completion (Anticipated)

April 16, 2020

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

November 8, 2017

First Posted (Actual)

November 9, 2017

Study Record Updates

Last Update Posted (Actual)

January 5, 2018

Last Update Submitted That Met QC Criteria

January 4, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA17002

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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Locations

3
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