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International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer

NCT03386734 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 989

Last updated 2024-07-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • ARCAGY/ GINECO GROUP

    collaborator OTHER

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    collaborator OTHER

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Principal Investigators

  • Fabrice Lecuru, MD PhD · Institut Curie

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-03
Primary Completion
2027-05-31
Completion
2029-05-31

Countries

  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • France
  • Germany
  • India
  • Italy
  • Japan
  • Norway
  • Slovakia
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03386734 on ClinicalTrials.gov