Research of Circulating Tumor Cells Released During Cervi... | NCT04770090

Studies
Research of Circulating Tumor Cells Released During Cervical Cancer Surgery

NCT04770090

Sponsor

University Hospital, Montpellier

Status

Active, not recruiting

Last Update Posted

Jun 22, 2026Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Cervical Cancer Stage IA1
Cervical Cancer Stage IB1
Cervical Cancer Stage IA2
Cervical Cancer Stage IB2

Interventions

Blood samples

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2022Actual

Primary Completion Date

Dec 5, 2022Actual

Completion Date

Dec 5, 2027Estimated

First Submitted Date

Feb 4, 2021

First Submission Date that Met QC Criteria

Feb 22, 2021

First Posted Date

Feb 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2026

Last Update Posted Date

Jun 22, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

University Hospital, MontpellierOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Early stage cervical cancer	Experimental	Patients with cervical cancer eligible for surgery, stage IA1 to IB2	Other: Blood samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood samples	Other	Peripheral blood samples at the beginning of surgery, after pneumoperitoneum creation and uterine pedicles coagulation.	Early stage cervical cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of gynaecology, Montpellier University Hospital		Montpellier		34295	France
Institut du Cancer de Montpellier - Val d'Aurelle

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms
D009360	Neoplastic Cells, Circulating

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided