Clinical trial NCT04770090: Research of Circulating Tumor Cells Released During Cervical Cancer Surgery
Official title: Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Cervical Cancer Surgery
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: 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
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Nīmes
name: Institut du Cancer de Montpellier - Val d'Aurelle
name: Laboratoire Cellules Circulantes Rares Humaines
First posted: 2021-02-25
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of circulating tumor cell detected after cervical cancer surgery.
timeFrame: Within 48 hours after surgery.
Secondary outcomes:
measure: Evaluation of disease-free survival
timeFrame: Two points at the 3rd and 5th years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Department of gynaecology, Montpellier University Hospital
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier - Val d'Aurelle
city: Nimes
country: France
facility: CHU de Nîmes
Study officials:
References: