Clinical Trial

The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.

Study acronym: ITCMicroUtCa
Recruiting
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Record status
This record was last updated August 17, 2022 (before its estimated January 2025 completion). Its status may not reflect the trial's current state.
Summary
The role of small-volume lymph node disease (ITC and micro metastases) among patients with endometrial or cervical cancer submitted to sentinel node (SLN) procedure is not clearly defined. This study was designed to create a dataset of patients with lymph nodal disease. Data on type and volume of lymph nodal disease, therapeutic choices and oncological outcomes (DFS, OS, recurrence rate) will be collected and analyzed. This will allow to define the groups of patients who may need or for whom it can be avoided any adjuvant treatment on the basis of lymph node status.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2020-05-21; most recent amendment 2022-08-15.
Trial Details
NCT Number NCT04403867
Lead Sponsor Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions Endometrial Cancer, Cervical Cancer, Sentinel Lymph Node, Micrometastasis, Sentinel Lymph Node Biopsy, Endometrium Tumor, Endometrial Neoplasms, Cervical Neoplasm +3 more
Enrollment 500 participants
Start Date 2020-01-02
Primary Completion 2025-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2022-08-17