NCT04770090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2022

Completed
Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

February 4, 2021

Last Update Submit

July 7, 2025

Conditions

Cervical Cancer Stage IA1Cervical Cancer Stage IB1Cervical Cancer Stage IA2Cervical Cancer Stage IB2

Keywords

Cervical cancerCirculating tumor cellCoelioscopyDisease-free survivalLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • 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)

    Within 48 hours after surgery.

Secondary Outcomes (1)

  • Evaluation of disease-free survival

    Two points at the 3rd and 5th years

Study Arms (1)

Early stage cervical cancer

EXPERIMENTAL

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

Other: Blood samples

Interventions

Blood samplesOTHER

Peripheral blood samples at the beginning of surgery, after pneumoperitoneum creation and uterine pedicles coagulation.

Early stage cervical cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 that may have an impact on the prognosis of cervical cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of gynaecology, Montpellier University Hospital

Montpellier, 34295, France

Location

Institut du Cancer de Montpellier - Val d'Aurelle

Montpellier, 34298, France

Location

CHU de Nîmes

Nîmes, France

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsNeoplastic Cells, Circulating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 25, 2021

Study Start

March 10, 2022

Primary Completion

August 22, 2022

Study Completion

August 22, 2022

Last Updated

July 10, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)