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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 \[micrometastasis and isolated tumor cells\])

Locations
Other Locations
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
Contact Information
Primary
Fabio Martinelli, MD
fabio.martinelli@istitutotumori.mi.it
+390223903322
Time Frame
Start Date: 2020-01-02
Estimated Completion Date: 2027-01
Participants
Target number of participants: 500
Treatments
Endometrial cancer patients
Patients submitted to Sentinel Lymph Node (SLN) procedure. Patients with lymph nodal disease (macrometastasis, micrometastasis, isolated tumor cells).
Cervical cancer patients
Patients submitted to Sentinel Lymph Node (SLN) procedure. Patients with lymph nodal disease (macrometastasis, micrometastasis, isolated tumor cells).
Related Therapeutic Areas
Sponsors
Leads: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

This content was sourced from clinicaltrials.gov