Research of Circulating Tumor Cells Released During Cervical Cancer Surgery

Cervical Cancer Stage IB1 Clinical Trial

— CTC-COL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04770090
• Other study ID #: RECHMPL20_0090
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2021
• Est. completion date: November 16, 2029

Study information

• Verified date: April 2023
• Source: University Hospital, Montpellier
• Contact: Gauthier Rathat, MD
• Phone: +33.4.67.33.64.21
• Email: g-rathat[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 16, 2029
• Est. primary completion date: May 16, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer Stage IA1
• Cervical Cancer Stage IA2
• Cervical Cancer Stage IB1
• Cervical Cancer Stage IB2
• Neoplastic Cells, Circulating
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Department of gynaecology, Montpellier University Hospital	Montpellier
France	Institut du Cancer de Montpellier - Val d'Aurelle	Montpellier
France	CHU de Nîmes	Nimes

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Centre Hospitalier Universitaire de Nimes, Institut du Cancer de Montpellier - Val d'Aurelle, Laboratoire Cellules Circulantes Rares Humaines

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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