Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery.

NCT04021459 | Completed

• 1 other identifier: RECHMPL19_0178
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Endometrial Cancer

Keywords

endometrial cancer; circulating tumor cells; laparoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quantitative assessment

  Before surgery and during surgery

Study Arms (1)

women with endometrial cancer

OTHER

Procedure: blood samples

Interventions

blood samples 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.

women with endometrial cancer

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with an other cancer

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

Montpellier University Hospital

Montpellier, 34295, France

Location

CHU de Nîmes

Nîmes, 30029, France

Location

Related 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. doi: 10.3390/biom13030428.

  PMID: 36979364 RESULT

MeSH Terms

Conditions

Endometrial Neoplasms; Neoplastic Cells, Circulating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Gauthier RATHAT, PHD

  University of Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: women with endometrial cancer

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 16, 2019
• Study Start: September 16, 2019
• Primary Completion: September 15, 2021
• Study Completion: September 16, 2021
• Last Updated: October 3, 2023

Record last verified: 2021-09

Locations

FR (2)