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

Primary Purpose

Cervical Cancer Stage IA1, Cervical Cancer Stage IB1, Cervical Cancer Stage IA2

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer Stage IA1 focused on measuring Cervical cancer, Circulating tumor cell, Coelioscopy, Disease-free survival, Laparoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Woman >18 years old
  • Cervical cancer confirmed by histology
  • Early stage eligible for immediate surgical treatment (or post-brachytherapy): stage IA1 and 1A2 with emboli, and stages IB1-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

Sites / Locations

  • Department of gynaecology, Montpellier University HospitalRecruiting
  • Institut du Cancer de Montpellier - Val d'AurelleRecruiting
  • CHU de NîmesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Early stage cervical cancer

Arm Description

Patients with cervical cancer eligible for surgery, stage IA1 to IB2

Outcomes

Primary Outcome Measures

Number of circulating tumor cell detected after cervical cancer 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)

Secondary Outcome Measures

Evaluation of disease-free survival
The disease-free survival will be evaluated at 3 and 5 years post-operatively

Full Information

First Posted
February 4, 2021
Last Updated
April 17, 2023
Sponsor
University Hospital, Montpellier
Collaborators
Centre Hospitalier Universitaire de Nīmes, Institut du Cancer de Montpellier - Val d'Aurelle, Laboratoire Cellules Circulantes Rares Humaines
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1. Study Identification

Unique Protocol Identification Number
NCT04770090
Brief Title
Research of Circulating Tumor Cells Released During Cervical Cancer Surgery
Acronym
CTC-COL
Official Title
Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Cervical Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2021 (Actual)
Primary Completion Date
May 16, 2025 (Anticipated)
Study Completion Date
November 16, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Centre Hospitalier Universitaire de Nīmes, Institut du Cancer de Montpellier - Val d'Aurelle, Laboratoire Cellules Circulantes Rares Humaines

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer Stage IA1, Cervical Cancer Stage IB1, Cervical Cancer Stage IA2, Cervical Cancer Stage IB2
Keywords
Cervical cancer, Circulating tumor cell, Coelioscopy, Disease-free survival, Laparoscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early stage cervical cancer
Arm Type
Experimental
Arm Description
Patients with cervical cancer eligible for surgery, stage IA1 to IB2
Intervention Type
Other
Intervention Name(s)
Blood samples
Intervention Description
Peripheral blood samples at the beginning of surgery, after pneumoperitoneum creation and uterine pedicles coagulation.
Primary Outcome Measure Information:
Title
Number of circulating tumor cell detected after cervical cancer surgery.
Description
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)
Time Frame
Within 48 hours after surgery.
Secondary Outcome Measure Information:
Title
Evaluation of disease-free survival
Description
The disease-free survival will be evaluated at 3 and 5 years post-operatively
Time Frame
Two points at the 3rd and 5th years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gauthier Rathat, MD
Phone
+33.4.67.33.64.21
Email
g-rathat@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Martha Duraes, MD
Phone
+33.6.31.32.91.58
Email
m-duraes@chu-montpellier.fr
Facility Information:
Facility Name
Department of gynaecology, Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha DURAES, MD
Phone
+33.6.31.32.91.58
Email
m-duraes@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Martha DURAES, MD
First Name & Middle Initial & Last Name & Degree
Gauthier RATHAT, MD
First Name & Middle Initial & Last Name & Degree
Sarah FRANCINI, MD
Facility Name
Institut du Cancer de Montpellier - Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Emmanuel COLOMBO, MD PhD
Email
Pierre-Emmanuel.Colombo@icm.montpellier.fr
First Name & Middle Initial & Last Name & Degree
Pierre Emmanuel COLOMBO, MD PhD
First Name & Middle Initial & Last Name & Degree
Anne MOURREGOT, MD
Facility Name
CHU de Nîmes
City
Nimes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine FERRER, MD
Email
catherine.ferrer@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Nathalie RUMEAU, CRA
Email
nathalie.RUMEAU@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Catherine MARSOLIER FERRER, MD
First Name & Middle Initial & Last Name & Degree
Renaud DE TAYRAC, MD PhD
First Name & Middle Initial & Last Name & Degree
Florent MASIA, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Research of Circulating Tumor Cells Released During Cervical Cancer Surgery

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