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Taking people in ItalyNo phase

Studies small lymph node spread in uterine and cervical cancer patients

Observes patients with endometrial or cervical cancer who had sentinel lymph node surgery.

Plain-language title generated from the registry record
Registry title: The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.

Key facts

Where
Milan, ItalySee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women with early stage endometrial or cervical cancer who are having a sentinel lymph node procedure and whose lymph nodes contain cancer.

Age
18 years or older
Sex
Women only
Disease stage
Early stage endometrial cancer or early stage cervical cancer, with cancer found in the lymph nodes (large deposits, micrometastasis or isolated tumor cells).
Biomarker or test result
Sentinel lymph nodes checked by standard ultra-staging or one-step nucleic acid amplification (OSNA) for cancer spread.

Main reasons for not taking part

  • Another cancer in the past 5 years or at the same time, other than non-melanoma skin cancer
  • Advanced or metastatic endometrial cancer
  • Locally advanced or metastatic cervical cancer

Read by machine on 12 November 2026.

Where in Italy

  • Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyContact: Fabio Martinelli, MDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Trial code
NCT04403867
Record updated
17 August 2022
Original description
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.Read full original descriptionShow less

The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Uterine Cancers (Endometrial/Cervical) Submitted to Sentinel Lymph Nodes (SLN) Procedure: an Observational Study

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.

Inclusion: 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: Previous (<5 years) or concomitant malignancy other than non-melanoma skin cancer; Advanced/metastatic endometrial cancer; Locally advanced/metastatic cervical cancer.

ClinicalTrials.gov NCT04403867