Status:
RECRUITING
The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Endometrial Cancer
Cervical Cancer
Eligibility:
FEMALE
18+ years
Brief 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...
Eligibility Criteria
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
Key Trial Info
Start Date :
January 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04403867
Start Date
January 2 2020
End Date
January 1 2027
Last Update
August 17 2022
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133