CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 600 enrolled
Drug / intervention
Sentinel lymph node biopsy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02494063
NCT02494063N/ACompleted
CompareCT.gov

A Prospective Observational Trial on Sentinel Lymph Node Biopsy in Patients With Early Stage Cervical Cancer

Charles University, Czech Republic·observational·Posted Jul 10, 2015·Updated Feb 8, 2024

In Brief

An observational study evaluating Sentinel lymph node biopsy and At least unilateral systematic pelvic lymph node dissection for Cervical Cancer. Completed, enrolled 600 participants across 1 site.

Detailed Summary

To evaluate whether a less radical surgical approach with sentinel lymph node biopsy is non-inferior to treatment with systematic pelvic lymphadenectomy. The null hypothesis is that the recurrence rate after SLN biopsy is non-inferior to the reference recurrence rate of 7 % (at the 24th month of follow-up) in patients after systematic pelvic lymphadenectomy, but that the less radical surgery is associated with significantly lower postoperative morbidity.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer
CountriesCzechia
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 10, 2015
Enrollment StartJun 1, 2016
Primary CompletionDec 1, 2022
Study CompletionFeb 1, 2024
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 11.0 years ago

Interventions

Sentinel lymph node biopsyprocedure

Bilateral sentinel lymph node biopsy, pathologic ultrastaging

At least unilateral systematic pelvic lymph node dissectionprocedure