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

  • STATUS
    Recruiting
  • End date
    Jan 5, 2027
  • participants needed
    500
  • sponsor
    Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Updated on 19 February 2024
cancer
immunomodulator
metastasis
sentinel node
tumor cells
lymphadenectomy
cervical cancer stage
pathologic examination
pathological evaluation
stage cervical cancer
nucleic acid amplification
adjuvant
cervical cancer
endometrial cancer
lymph node disease

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.

Details
Condition Cervical Cancer, Cervical Cancer, Endometrial Carcinoma, endometrial cancer, Uterine Cancer, Uterine Cancer, Metastasis, Brain Metastases, Liver Metastases, neoplasm metastasis, Sentinel Lymph Node Biopsy, Sentinel Lymph Node, Brain Metastases, Lymph Node Metastases, Liver Metastases, neoplasm metastasis, endometrial cancer, Lymph Node Disease
Age 18years - 100years
Treatment Sentinel lymph node (SLN) biosy +/- lymphadenectomy
Clinical Study IdentifierNCT04403867
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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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