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
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
500 participants
Jan 2, 2020
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria3
- Previous (\<5 years) or concomitant malignancy other than non-melanoma skin cancer
- Advanced/metastatic endometrial cancer
- Locally advanced/metastatic cervical cancer
Interventions
Evaluation of type and volume of lymph nodal disease
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04403867