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

Launched by FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI, MILANO · May 21, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the role of small amounts of cancer cells in lymph nodes (called micrometastasis and isolated tumor cells) in women with early-stage endometrial and cervical cancer. The aim is to gather information about how these small-volume cancers affect treatment choices and outcomes, such as survival rates and the chance of the cancer coming back. By analyzing this data, researchers hope to identify which patients may benefit from additional treatments after their surgery and which might not need them.

To participate in this trial, women aged 65 to 74 who are undergoing a specific procedure called sentinel lymph node biopsy for early-stage endometrial or cervical cancer may be eligible. Participants will have their lymph nodes examined closely to see if there are any signs of cancer. By joining this study, they can contribute to important research that may help improve treatment decisions for future patients.

Gender

FEMALE

Eligibility criteria

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