Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT03680833
Brief Summary:
Evaluation of sensitivity of Sentinel lymph nodes for detecting nodal metastases in cervical cancer
Detailed Description:
Consecutive women with stage 1a2-2a1 cervical cancer scheduled for surgery will be approached for eligibility by defined criteria.
Sentinel nodes will be detected by a combined use of Indocyanine green and Tc99 radiocolloid ( first 75 patients) and for the continuation with either the combined use or the best performing of those tracers.
Technical success rates, adverse events (related study intervention and overall) sensitivity and negative predictive values will be estimated.
An interim analyse will be performed after 34 node positive patients based on the Fleming two stage analyse. The null hypothesis of sensitivity of 85% will be tested against an estimated sensitivity of 95%. At this stage the study may be closed for futility, closed as hull hypothesis is rejected or continued to reach another 28 node positive patients.
As a full pelvic lymphadenectomy will be performed after detection of sentinel nodes patient will act ast their own controls.
Study:
NCT03680833
Study Brief:
Protocol Section:
NCT03680833