The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.
The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Uterine Cancers (Endometrial/Cervical) Submitted to Sentinel Lymph Nodes (SLN) Procedure: an Observational Study
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.
Survival (Disease free survival [DFS], overall survival [OS])
Usage of adjuvant therapy in case of small-volume lymph node disease
Sentinel lymph node (SLN) biosy +/- lymphadenectomy
Study Arms / Comparison Groups
Endometrial cancer patients
Description: Patients submitted to Sentinel Lymph Node (SLN) procedure. Patients with lymph nodal disease (macrometastasis, micrometastasis, isolated tumor cells).
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
January 2, 2020
Primary Completion Date
Inclusion Criteria: - Early stage endometrial cancer scheduled for SLN procedure - Early stage cervical cancer scheduled for SLN procedure - Pathological evaluation of SLNs with standard ultra-staging or one-step nucleic acid amplification (OSNA) for the detection of metastasis - Presence of lymph nodes metastasis (macrometastasis or low volume disease [micrometastasis and isolated tumor cells]) Exclusion Criteria: - Previous (<5 years) or concomitant malignancy other than non-melanoma skin cancer - Advanced/metastatic endometrial cancer - Locally advanced/metastatic cervical cancer
18 Years - N/A
Accepts Healthy Volunteers
Fabio Martinelli, MD, +390223903322, [email protected]
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Fabio Martinelli, MD, Principal Investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano