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
Where in Italy
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
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.