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Role of Senescence in the Development of Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT03338985
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief 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.


Condition or disease Intervention/treatment Phase
Endometrial Hyperplasia and Endometrial Cancers Genetic: Genetic analysis Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Role of Senescence in the Development of Endometrial Cancer
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : October 16, 2019
Estimated Study Completion Date : April 16, 2020

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.




Primary Outcome Measures :
  1. Genetic imbalances [ Time Frame: Day 0 ]
    Genetic aberrations detected by comparative genomic hybridization (CGH arry)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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


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): NCT03338985


Contacts
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Contact: Emilie RAIMOND 0326789598 eraimond@chu-reims.fr

Locations
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France
Damien JOLLY Recruiting
Reims, France
Contact: Emilie RAIMOND       eraimond@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03338985     History of Changes
Other Study ID Numbers: PA17002
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyperplasia
Endometrial Neoplasms
Endometrial Hyperplasia
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female