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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

About this trial

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 criteria

Qualifiers

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])

Disqualifiers

Previous (<5 years) or concomitant malignancy other than non-melanoma skin cancer

Advanced/metastatic endometrial cancer

Locally advanced/metastatic cervical cancer

Trial design

Treatments tested in this trial

  • Sentinel lymph node (SLN) biosy +/- lymphadenectomy

Treatment groups

500 Participants
are divided into 2 treatment groups