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

Recruitingn/aAges 18 Years - anyFemaleFondazione IRCCS Istituto Nazionale dei Tumori, M…
NCT04403867 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Sentinel lymph node (SLN) biosy +/- lymphadenectomy
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Where

1 site
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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