Examining the impact of small-volume lymph node disease in endometrial and cervical cancer
The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Uterine Cancers (Endometrial/Cervical) Submitted to Sentinel Lymph Nodes (SLN) Procedure: an Observational Study
This study is trying to see how small amounts of cancer in lymph nodes affect treatment choices and outcomes for people with early-stage endometrial and cervical cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT04403867 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with early-stage endometrial or cervical cancer scheduled for sentinel lymph node procedures.
Not a fit: Patients with advanced or metastatic forms of endometrial or cervical cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help tailor treatment plans for patients with endometrial and cervical cancer, potentially reducing unnecessary adjuvant therapies.
How similar studies have performed: Other studies have explored similar approaches in lymph node evaluation, indicating potential for meaningful insights, though this specific focus on micrometastasis is less common.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.