Research of Circulating Tumor Cells Released During Cervical Cancer Surgery (CTC-COL)

July 7, 2025 updated by: University Hospital, Montpellier

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

Cervical cancer is a rare pathology. Recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. It could be explained by the spread of circulating tumor cells (CTC) due to tumor mobilization during different steps of the surgery.

The primary goal is to evaluate the spread of CTC during surgery on peripheral blood samples.

The secondary outcome is to evaluation the disease-free survival at 3 and 5 years postoperatively.

20 patients with early stage cervical (IA1 to IB2) eligible to coelioscopic stadification and laparoscopic surgery will be included.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CTC detection could be a pronostic factor for cancer evolution. Cervical cancer is a rare pathology with increased death rate.

Despite recommendations for coelioscopic treatment of < 4cm cervical cancers, recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. It could be explained by the spread of circulating tumor cells (CTC) due to tumor mobilization during coelioscopic stadification and laparoscopic surgery.

Hypothesis : Mobilization of the tumor during coelioscopy leads to CTC spread. This spread could explain the recurrence of cervical cancer.

This pilot study will evaluate the possibility of CTC detection during surgery. The primary goal is to evaluate the spread of CTC during the different steps of surgery on peripheral blood samples.

The secondary outcome is to evaluation the disease-free survival at 3 and 5 years postoperatively.

20 patients with early stage cervical (IA1 to IB2) eligible to coelioscopic stadification and laparoscopic surgery will be included.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34298
        • Institut du Cancer de Montpellier - Val d'aurelle
      • Montpellier, France, 34295
        • Department of gynaecology, Montpellier University Hospital
      • Nimes, France
        • CHU de Nîmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Woman >18 years old
  • Cervical cancer confirmed by histology
  • Early stage eligible for immediate surgical treatment (or post-brachytherapy): stages IA1, 1A2, 1B1 and IB2 with or without emboli determined by MRI performed as part of the treatment
  • Histology : epidermoid carcinoma and adenocarcinoma
  • Valid Social Security
  • Wrote consent

Exclusion Criteria:

  • Advanced stage (Stage IB3 and more)
  • Concomitant cancer
  • Pregnant or breastfeeding woman
  • Vulnerable person (Article L1121-6 of the Public Health Code)
  • Participation to other study with an exclusion period still in progress
  • Participation to other study that may have an impact on the prognosis of cervical cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early stage cervical cancer
Patients with cervical cancer eligible for surgery, stage IA1 to IB2
Other: Blood samples
Peripheral blood samples at the beginning of surgery, after pneumoperitoneum creation and uterine pedicles coagulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of circulating tumor cell detected after cervical cancer surgery.
Time Frame: Within 48 hours after surgery.
Detection of the presence of at least one circulating tumor cell from blood samples taken during surgery (one CTC per 7.5mL of blood or increase of at least one CTC if CTC is present pre-operatively)
Within 48 hours after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of disease-free survival
Time Frame: Two points at the 3rd and 5th years
The disease-free survival will be evaluated at 3 and 5 years post-operatively
Two points at the 3rd and 5th years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Centre Hospitalier Universitaire de Nīmes
Institut du Cancer de Montpellier - Val d'Aurelle
Laboratoire Cellules Circulantes Rares Humaines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Actual)

August 22, 2022

Study Completion (Actual)

August 22, 2022

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

July 10, 2025

Last Update Submitted That Met QC Criteria

July 7, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL20_0090

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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