Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery.

Not Applicable

Completed

• Conditions: Endometrial Cancer
• Interventions: Procedure: blood samples

• Registration Number: NCT04021459
• Lead Sponsor: University Hospital, Montpellier

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).

Study Timeline

• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-16
• Study Start: 2019-09-16
• Status Verified: 2021-09
• Primary Completion: 2021-09-15
• Study Completion: 2021-09-16
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• Patients with endometrial cancer
• Being affiliated or benefiting from a French social security system

Exclusion Criteria

• Patients with an other cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
women with endometrial cancer	blood samples	-

Primary Outcome Measures

Name	Time	Method
Qualitative assessment	During surgery (at the ligature of the ovarian ligament)	Presence or not of at least one CTC during endometrial cancer surgery detected on two venipuncture site (peripheral and ovarian vein).

Secondary Outcome Measures

Name	Time	Method
Quantitative assessment	Before surgery and during surgery	Number of CTC detected from each sampling

Trial Locations

Locations (2)

CHU de Nîmes; 🇫🇷 Nîmes, France

Montpellier University Hospital; 🇫🇷 Montpellier, France