Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery.

Study Overview
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Brief Summary
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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
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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).

Official Title
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Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Procedure: blood samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with endometrial cancer Being affiliated or benefiting from a French social security system Exclusion Criteria: Patients with an other cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: women with endometrial cancer
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: women with endometrial cancer<br> | Procedure: blood samples<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative assessment | Presence or not of at least one CTC during endometrial cancer surgery detected on two venipuncture site (peripheral and ovarian vein). | During surgery (at the ligature of the ovarian ligament) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative assessment | Number of CTC detected from each sampling | Before surgery and during surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrial cancer, circulating tumor cells, laparoscopy