Research of Circulating Tumor Cells Released During Cervical Cancer Surgery (CTC-COL)
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
200 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Gauthier Rathat, MD; Martha Duraes, MD
Data sourced from clinicaltrials.gov
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