RecruitingNCT04403867

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

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

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Enrollment

500 participants

Start Date

Jan 2, 2020

Study Type

OBSERVATIONAL

Conditions

Cervical Cancer Endometrial Cancer Sentinel Lymph Node Lymph Node Metastases Sentinel Lymph Node Biopsy Endometrial Neoplasms Lymph Node Disease Micrometastasis Endometrium Tumor Cervical Neoplasm Cervical Tumor

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This multicenter study looks at whether very small amounts of cancer cells found in lymph nodes (called micrometastases or isolated tumor cells) affect outcomes for women with early-stage uterine or cervical cancer who have undergone a sentinel lymph node procedure. **You may be eligible if...** - You have been diagnosed with early-stage endometrial (uterine) cancer or early-stage cervical cancer - You are scheduled for a sentinel lymph node biopsy (a procedure to check nearby lymph nodes for cancer) - Small amounts of cancer were found in one or more lymph nodes **You may NOT be eligible if...** - You have had another cancer in the last 5 years (excluding certain skin cancers) - Your endometrial or cervical cancer is advanced or has already spread to distant sites Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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