Research of Circulating Tumor Cells Released During Cervical Cancer Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer Stage IA1, Cervical Cancer Stage IB1, Cervical Cancer Stage IA2, Cervical Cancer Stage IB2

Intervention / Treatment
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* Other: Blood samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early stage cervical cancer<br>Patients with cervical cancer eligible for surgery, stage IA1 to IB2 | Other: Blood samples<br>* Peripheral blood samples at the beginning of surgery, after pneumoperitoneum creation and uterine pedicles coagulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cancer, Circulating tumor cell, Coelioscopy, Disease-free survival, Laparoscopy