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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 Endometrial and Cervical Cancer. A Multicenter Study.

Recruiting
18 years and older
Female
Phase N/A
  • Technical (Original)
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Overview

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 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

Study details
    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

NCT04403867

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

28 January 2024

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