Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04021459
Recruitment Status : Not yet recruiting
First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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 Not Applicable

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: women 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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Qualitative assessment [ Time Frame: 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 :
  1. Quantitative assessment [ Time Frame: Before surgery and during surgery ]
    Number of CTC detected from each sampling



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with an other cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04021459


Contacts
Layout table for location contacts
Contact: Gauthier RATHAT, PHD 0467336532 g-rathat@chu-montpellier.fr
Contact: Sarah FRANCINI, resident s-francini@chu-montpellier.fr

Locations
Layout table for location information
France
Montpellier University Hospital Active, not recruiting
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Layout table for investigator information
Principal Investigator: Gauthier RATHAT, PHD University of Montpellier

Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04021459     History of Changes
Other Study ID Numbers: RECHMPL19_0178
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
endometrial cancer
circulating tumor cells
laparoscopy

Additional relevant MeSH terms:
Layout table for MeSH terms
Endometrial Neoplasms
Neoplastic Cells, Circulating
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes