Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery.

Endometrial Cancer Clinical Trial

— E-CTC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04021459
• Other study ID #: RECHMPL19_0178
• Status: Completed
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: September 16, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 16, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with endometrial cancer

• Being affiliated or benefiting from a French social security system

Exclusion Criteria:

• Patients with an other cancer

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Neoplastic Cells, Circulating

Intervention

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.

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quantitative assessment	Number of CTC detected from each sampling	Before surgery and during surgery