Cervical Cancer Stage IA1, Cervical Cancer Stage IA2, Cervical Cancer Stage IB1, Cervical Cancer Stage IB2
Conditions
Keywords
Cervical cancer, Circulating tumor cell, Coelioscopy, Disease-free survival, Laparoscopy
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.
Interventions
OTHERBlood samples
Peripheral blood samples at the beginning of surgery, after pneumoperitoneum creation and uterine pedicles coagulation.
Sponsors
University Hospital, Montpellier
Centre Hospitalier Universitaire de Nīmes
Institut du Cancer de Montpellier - Val d'Aurelle
Laboratoire Cellules Circulantes Rares Humaines
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of circulating tumor cell detected after cervical cancer surgery. | Within 48 hours after 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of disease-free survival | Two points at the 3rd and 5th years | The disease-free survival will be evaluated at 3 and 5 years post-operatively |
Countries
France
Outcome results
None listed