E-CTC: Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery.

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT04021459

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

7.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Procedure: blood samples	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

women with endometrial cancerwomen with endometrial cancer

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Sep 16, 2019

Actual Primary Completion Date :

Sep 15, 2021

Actual Study Completion Date :

Sep 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: women with endometrial cancer	Procedure: blood samples 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.

Arm

Intervention/Treatment

Other: women with endometrial cancer

Procedure: blood samples

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.

Outcome Measures

Primary Outcome Measures

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

Quantitative assessment [Before surgery and during surgery]
Number of CTC detected from each sampling

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Patients with an other cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montpellier University Hospital	Montpellier		France	34295
2	CHU de Nîmes	Nîmes		France	30029

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

Study Director: Gauthier RATHAT, PHD, University of Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT04021459

Other Study ID Numbers:

RECHMPL19_0178

First Posted:

Jul 16, 2019

Last Update Posted:

Sep 20, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Montpellier

endometrial cancer

circulating tumor cells

laparoscopy

Additional relevant MeSH terms:

Endometrial Neoplasms

Neoplastic Cells, Circulating

Study Results

No Results Posted as of Sep 20, 2021