Trials / Completed
CompletedNCT04770090
Research of Circulating Tumor Cells Released During Cervical Cancer Surgery
Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Cervical Cancer Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- University Hospital, Montpellier · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Cervical Cancer Stage IA1
- Cervical Cancer Stage IB1
- Cervical Cancer Stage IA2
- Cervical Cancer Stage IB2
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Blood samples | Peripheral blood samples at the beginning of surgery, after pneumoperitoneum creation and uterine pedicles coagulation. |
Timeline
- Start date
- 2022-03-10
- Primary completion
- 2022-08-22
- Completion
- 2022-08-22
- First posted
- 2021-02-25
- Last updated
- 2025-07-10
Locations
3 sites across 1 country: France
Source: ClinicalTrials.gov record NCT04770090. Inclusion in this directory is not an endorsement.