Back to resultsRole of Senescence in the Development of Endometrial Cancer
Primary Purpose
Endometrial Hyperplasia and Endometrial Cancers
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Genetic analysis
Sponsored by
About this trial
This is an interventional basic science trial for Endometrial Hyperplasia and Endometrial Cancers
Eligibility 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
Sites / Locations
- Damien JOLLYRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group "cases patients"
Arm Description
patients with endometrial hyperplasia or endometrial cancers
Outcomes
Primary Outcome Measures
Genetic imbalances
Genetic aberrations detected by comparative genomic hybridization (CGH arry)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03338985
Brief Title
Role of Senescence in the Development of Endometrial Cancer
Official Title
Role of Senescence in the Development of Endometrial Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
October 16, 2019 (Anticipated)
Study Completion Date
April 16, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
make a pangenomic investigation of genetic abnormalities in atypical endometrial hyperplasia and endometrial cancers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Hyperplasia and Endometrial Cancers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group "cases patients"
Arm Type
Experimental
Arm Description
patients with endometrial hyperplasia or endometrial cancers
Intervention Type
Genetic
Intervention Name(s)
Genetic analysis
Intervention Description
Genetic analysis of the samples taken during the surgery (hysterectomy or curettage resection) using CGH array technique.
Primary Outcome Measure Information:
Title
Genetic imbalances
Description
Genetic aberrations detected by comparative genomic hybridization (CGH arry)
Time Frame
Day 0
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie RAIMOND
Phone
0326789598
Email
eraimond@chu-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie RAIMOND
Email
eraimond@chu-reims.fr
12. IPD Sharing Statement
Learn more about this trial
Role of Senescence in the Development of Endometrial Cancer
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