Endometrial Cancer and Array CGH

July 12, 2016 updated by: CHU de Reims

Endometrial Cancer: Evaluation of Genetic Imbalances in the Carcinogenesis Process

Medical context:

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 dentified (P53, PTEN, PIK3CA, ß-catenin, K-ras ...). It is thus conceivable that like that enable genomic tools used in breast cancer today (Oncotype DX, MammaPrint), correlation between the tumor profile and life project in the case of cancer the endometrium could be done. A study is already underway at the Reims University Hospital with funding from the League against cancer and AOL in 2010 CHU Reims. It should identify the specific alterations of nosologic continuum of pathology and characterize areas of interest on the genome. To date, 39 patients with endometrial cancer and 15 patients with endometrial hyperplasia (patients 'cases') were included in the study. For this study, 10 patients exhibiting neither cancer nor endometrial hyperplasia were also included. Samples of these 10 patients 'witnesses' were pooled to serve as a reference for analyzing patients 'cases'.

objectives: In continuation of the study began in November 2009, refine the study of genomic imbalances highlighted hyperplasia and endometrial cancer by studying the in correlation between genomics and proteomics by immunohistochemical studies and analyzing the microsatellite instability.

To study the prognostic role of genetic factors in patients carriers of a disease endometrial (cancer or hyperplasia).

Material and methods :

Experimental Design: Cross-sectional study in inclusion prospective multi-center followed by a cohort study of patients 'cases'.

Population / patients: in total, it is planned to include 72 patients with hyperplasia or endometrial cancer (22 patients included in the pre-study part funded by the League against cancer 50 patients included in the scope of the study funded by the 2010 AOL Chu Reims).

Plan of investigation: the study includes two phases:

Sectional study:

The inclusion of 10 patients "witnesses" has already been completed in the first project.

During the consultation in the obstetrics and gynecology department of the Reims University Hospital and the surgical department of the institute Jean Godinot, terms and objectives of the study have been and will be presented to patients where cancer or hyperplasia endometrial was diagnosed by achieving endometrial biopsy.

If the patient agrees to participate in the study, the management of its pathology (hysterectomy, hysteroscopy and curettage resection) will not be changed.

The samples taken during the surgery were analyzed and will be as provided in the first research project. Tumor karyotype, DNA extraction are performed on each sample fresh. A comparative genomic hybridization is conducted using the DNAs thus obtained.

Additional analyzes (immunohistochemistry and analysis of microsatellite instability) will be performed on all samples already obtained and on future withdrawals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

95

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

  • France
    • Reims
      • France, Reims, France, 51092
        • CHU Reims

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 with cancer or hyperplasia endometrial

Description

Inclusion Criteria:

  • Having a pathological diagnosis of hyperplasia or endometrial cancer
  • consent to participation in the study

Exclusion Criteria:

  • Not affiliated to a social security scheme

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Genetic: surgery
endometrial cancer
Genetic: surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
quantitative analysis of Ki67 by immunohistochemistry analysis
Time Frame: up to 1 year
up to 1 year
quantitative analysis of P53 by immunohistochemistry analysis
Time Frame: up to 1 year
up to 1 year
quantitative analysis of HER2 by immunohistochemistry analysis
Time Frame: up to 1 year
up to 1 year

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

November 1, 2010

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

July 4, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 14, 2016

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA11019

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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