NCT03386734

International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 989 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

SENTICOL III is large prospective multicenter international randomized study designed to validate the Sentinel Lymph Node (SLN) mapping technique in early cervical cancer. This "validation study" will compare the outcome of patients with negative SLN (experimental arm) vs patients with negative SLN + Pelvic Lymph Node dissection (PLN)(reference arm). There will be a "quality assurance" program which will be developed in participating centers with detailed requirements in terms of surgeons' qualifications, pathology qualification, SLN ultrastaging, standardization of the procedure, etc. as well as respect of the "safety algorithm".

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
PROCEDURE	SLN biopsy only	In experimental arm, SLN dissection only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.
PROCEDURE	SLN biopsy + PLN dissection	In active comparator arm, SLN dissection + full lymphadenectomy will be performed.

Timeline

• Start date: 2018-05-03
• Primary completion: 2027-05-01
• Completion: 2029-05-01
• First posted: 2017-12-29
• Last updated: 2024-07-08

Locations

106 sites across 14 countries: Belgium, Brazil, Canada, China, Czechia, France, Germany, India, Italy, Japan, Norway, Slovakia, Spain, Switzerland