Examining the impact of small-volume lymph node disease in endometrial and cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the role of micrometastasis and isolated tumor cells in patients with early-stage endometrial and cervical cancer undergoing sentinel lymph node procedures. It will collect and analyze data on the type and volume of lymph node disease, treatment choices, and oncological outcomes such as disease-free survival, overall survival, and recurrence rates. The goal is to identify patient groups that may or may not require adjuvant treatment based on their lymph node status.

Why it matters

Who can join: the full rules

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

Where it's running

• Fondazione IRCCS Istituto Nazionale dei Tumori
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Fabio Martinelli, MD — Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Study coordinator: Fabio Martinelli, MD
• Email: fabio.martinelli@istitutotumori.mi.it
• Phone: +390223903322

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.