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

NCT04403867 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2022-08-17

No results posted yet for this study

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.

Conditions

  • 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

Interventions

PROCEDURE

Sentinel lymph node (SLN) biosy +/- lymphadenectomy

Evaluation of type and volume of lymph nodal disease

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Principal Investigators

  • Fabio Martinelli, MD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-02
Primary Completion
2025-01-31
Completion
2027-01-31

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04403867 on ClinicalTrials.gov