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Endometrial Cancer and Array CGH

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ClinicalTrials.gov Identifier: NCT02833896
Recruitment Status : Completed
First Posted : July 14, 2016
Last Update Posted : July 14, 2016
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Cancer of the Endometrium Genetic: surgery

Study Design
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Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Endometrial Cancer: Evaluation of Genetic Imbalances in the Carcinogenesis Process
Study Start Date : November 2010
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016
Groups and Cohorts
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Group/Cohort Intervention/treatment
endometrial cancer Genetic: surgery
Control Genetic: surgery


Outcome Measures
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Primary Outcome Measures :
  1. quantitative analysis of Ki67 by immunohistochemistry analysis [ Time Frame: up to 1 year ]
  2. quantitative analysis of P53 by immunohistochemistry analysis [ Time Frame: up to 1 year ]
  3. quantitative analysis of HER2 by immunohistochemistry analysis [ Time Frame: up to 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with cancer or hyperplasia endometrial
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833896


Locations
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France
Chu Reims
France, Reims, France, 51092
Sponsors and Collaborators
CHU de Reims
More Information
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02833896    
Other Study ID Numbers: PA11019
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Uterine Diseases