Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery.

NCT ID: NCT04021459

Last Updated: 2023-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-16

Study Completion Date

2021-09-16

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).

Conditions

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Endometrial Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

women with endometrial cancer
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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women with endometrial cancer

Group Type OTHER

blood samples

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gauthier RATHAT, PHD

Role: STUDY_DIRECTOR

University of Montpellier

Locations

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Montpellier University Hospital

Montpellier, , France

Site Status

CHU de Nîmes

Nîmes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 36979364 (View on PubMed)

Other Identifiers

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RECHMPL19_0178

Identifier Type: -

Identifier Source: org_study_id

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