The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.
NCT04403867 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500
Last updated 2022-08-17
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.
Conditions
- Endometrial Cancer
- Cervical Cancer
- Sentinel Lymph Node
- Micrometastasis
- Sentinel Lymph Node Biopsy
- Endometrium Tumor
- Endometrial Neoplasms
- Cervical Neoplasm
- Cervical Tumor
- Lymph Node Metastases
- Lymph Node Disease
Interventions
- PROCEDURE
-
Sentinel lymph node (SLN) biosy +/- lymphadenectomy
Evaluation of type and volume of lymph nodal disease
Sponsors & Collaborators
-
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
lead OTHER
Principal Investigators
-
Fabio Martinelli, MD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-02
- Primary Completion
- 2025-01-31
- Completion
- 2027-01-31
Countries
- Italy
Study Locations
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