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Active Not Recruiting
NCT04770090
Research of Circulating Tumor Cells Released During Cervical Cancer Surgery
Conditions: Cervical Cancer Stage IA1, Cervical Cancer Stage IB1, Cervical Cancer Stage IA2, Cervical Cancer Stage IB2
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: University Hospital, Montpellier
Location: Department of gynaecology, Montpellier University Hospital Montpellier
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.
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
Source: ClinicalTrials.gov (NCT04770090). StuddyBuddy aggregates publicly available trial information.