Back to resultsResearch of Circulating Tumor Cells Released During Endometrial Cancer Surgery. (E-CTC)
Primary Purpose
Endometrial Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
Sponsored by
About this trial
This is an interventional screening trial for Endometrial Cancer focused on measuring endometrial cancer, circulating tumor cells, laparoscopy
Eligibility Criteria
Inclusion Criteria:
- Patients with endometrial cancer
- Being affiliated or benefiting from a French social security system
Exclusion Criteria:
- Patients with an other cancer
Sites / Locations
- Montpellier University Hospital
- CHU de Nîmes
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
women with endometrial cancer
Arm Description
Outcomes
Primary Outcome Measures
Qualitative assessment
Presence or not of at least one CTC during endometrial cancer surgery detected on two venipuncture site (peripheral and ovarian vein).
Secondary Outcome Measures
Quantitative assessment
Number of CTC detected from each sampling
Full Information
NCT ID
NCT04021459
First Posted
July 15, 2019
Last Updated
September 29, 2023
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT04021459
Brief Title
Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery.
Acronym
E-CTC
Official Title
Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
September 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the spread of Circulating Tumor Cells (CTC) during surgery in endometrial cancer. Although this cancer is often discovered at early stage, the risk of recurrence is estimated at 6 to 21%, according to grade. Early stage tumor is accessible for curative surgical treatment by laparoscopy but this kind of surgery may induce CTCs spread, and could be an explanation of this recurrence. Through this study, concordance between two blood punction sites, peripheral vein and ovarian vein, will be evaluated to detect these cells during surgery.
Detailed Description
The goal of this single-center clinical trial is to determine the best blood punction site to observe the spreading of CTC during surgery in endometrial cancer. CTCs are very rare events on blood and their detection require extremely sensitive technologies. This pilot study will investigate CTC spread during surgery on 10 patients with endometrial cancer.
The main objective is to compare venipuncture site for detection of CTCs in endometrial cancer during surgery. Blood samples are collected on a simple sampling (arm) compared to sampling as close as possible to the tumor (ovarian vein).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
endometrial cancer, circulating tumor cells, laparoscopy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
women with endometrial cancer
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
women with endometrial cancer
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
blood samples
Intervention Description
3 samples: One before surgery on the arm vein (peripheral)
Two during the surgery, on two different venipuncture site :
One on the arm vein (peripheral)
One on ovarian vein (close to the tumor) All samples will be tested by the CellSearch method.
Primary Outcome Measure Information:
Title
Qualitative assessment
Description
Presence or not of at least one CTC during endometrial cancer surgery detected on two venipuncture site (peripheral and ovarian vein).
Time Frame
During surgery (at the ligature of the ovarian ligament)
Secondary Outcome Measure Information:
Title
Quantitative assessment
Description
Number of CTC detected from each sampling
Time Frame
Before surgery and during surgery
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with endometrial cancer
Being affiliated or benefiting from a French social security system
Exclusion Criteria:
Patients with an other cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gauthier RATHAT, PHD
Organizational Affiliation
University of Montpellier
Official's Role
Study Director
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
36979364
Citation
Francini S, Duraes M, Rathat G, Macioce V, Mollevi C, Pages L, Ferrer C, Cayrefourcq L, Alix-Panabieres C. Circulating Tumor Cell Detection by Liquid Biopsy during Early-Stage Endometrial Cancer Surgery: A Pilot Study. Biomolecules. 2023 Feb 24;13(3):428. doi: 10.3390/biom13030428.
Results Reference
result
Learn more about this trial
Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery.
We'll reach out to this number within 24 hrs