Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Cervical Cancer Surgery (CTC-COL)

  • STATUS
    Recruiting
  • End date
    Nov 17, 2028
  • participants needed
    20
  • sponsor
    University Hospital, Montpellier
Updated on 18 October 2022

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 coelioscopy.

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 surgery will be included.

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 coelioscopy.

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 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 surgery will be included.

Details
Condition Cervical Cancer Stage IA1, Cervical Cancer Stage IB1, Cervical Cancer Stage IA2, Cervical Cancer Stage IB2
Treatment blood samples
Clinical Study IdentifierNCT04770090
SponsorUniversity Hospital, Montpellier
Last Modified on18 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Woman >18 years old
Cervical cancer confirmed by histology
Early stage eligible for immediate surgical treatment (or post-brachytherapy): stage IA1 and 1A2 with emboli, and stages IB1-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)
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
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