Investigating predictors of lymph node involvement in endometrial cancer
Histological and Molecular Characteristics Predict the Risk of Nodal Involvement in Endometrial Cancer: a Prospective Study
This study is trying to find out which factors in endometrial cancer patients can help predict if the cancer has spread to the lymph nodes, to improve treatment decisions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Locations | 1 site (Milan, Lombardy) |
| Trial ID | NCT05793333 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the histological and molecular profiles of patients with endometrial cancer to predict the risk of nodal metastases. It will involve collecting data on various genomic markers and histological characteristics, alongside sentinel node mapping to assess node positivity. The study seeks to identify specific predictors that could help in stratifying patients based on their risk of lymphatic spread. By understanding these predictors, the study hopes to improve clinical decision-making for endometrial cancer management.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with histologically confirmed endometrial cancer who have undergone sentinel node mapping and have relevant molecular genomic profiling data.
Not a fit: Patients with stage IVB endometrial cancer or those who withdraw consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with endometrial cancer based on their risk of nodal metastases.
How similar studies have performed: While this approach is focused on specific predictors in endometrial cancer, similar studies in other cancers have shown promise in using molecular and histological data to predict metastasis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent * Histologically confirmed endometrila cancer * Data on molecular genomic profiling (POLE mutated, p53 abnormalities, MMRd/MSI-H, and NSMP) * Data on histological characteristics of the ttumor * Execution of sentinel node mapping * Data on sentinel node status (negative vs. positive) Exclusion Criteria: * Stage IVB endoemtrial cancer * consent withdraw
Where this trial is running
Milan, Lombardy
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Lombardy, Italy (Recruiting)
Study contacts
- Study coordinator: Grazia M Casadei, ph.d.
- Email: grazia.casadei@istitutotumori.mi.it
- Phone: 917-275-6975
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.