The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer Using Sentinel Lymph Node Biopsy: An Observational Multicenter Study

What this Trial Is About

Researchers are studying the role of small-volume lymph node disease, including isolated tumor cells and micrometastases, in patients with early stage endometrial or cervical cancer who undergo a sentinel lymph node (SLN) procedure. The purpose is to collect and analyze data on the type and amount of lymph node disease, treatment decisions, and cancer outcomes such as disease-free survival, overall survival, and recurrence rates. Understanding these factors may help identify which patients require additional treatment based on their lymph node status. Participants in this observational study have early stage endometrial or cervical cancer and undergo sentinel lymph node biopsy, with or without lymphadenectomy. The lymph nodes are pathologically evaluated using ultra-staging or a nucleic acid amplification method to detect metastases. The study includes patients with lymph node metastases of varying sizes, including macrometastases and small-volume disease such as micrometastasis and isolated tumor cells. During the study, researchers will track cancer outcomes like survival and recurrence for about three years and monitor the use of additional therapies for up to six months. Data collection involves evaluating lymph node disease type and volume, treatment choices, and patient follow-up. The study is sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, and aims to improve understanding of how lymph node findings affect treatment decisions and outcomes in uterine cancers.

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