Real-world use of molecular classification for endometrial cancer
REal Word aPpLicAtion of Molecular Based Endometrial Cancer Classification: a Focus on POLE Evaluation in Clinical Practice
This project will try using molecular tests (POLE, p53, and mismatch-repair markers) in Italian hospitals to classify early-stage endometrial cancer and help guide adjuvant treatment decisions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 264 (estimated) |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, Roma) |
| Trial ID | NCT07555665 on ClinicalTrials.gov |
What this trial studies
This observational project collects questionnaire and clinical data from Italian hospitals that treat and surgically manage endometrial cancer to document real-world implementation of molecular classification. Sites will report use of surrogate immunohistochemistry markers (p53, MLH1, MSH2, MSH6, PMS2) and POLE testing where available to assign tumors to POLEmut, MMRd/MSI‑H, p53mut, or NSMP groups. The dataset will link molecular subgrouping with staging, adjuvant treatment choices, and early outcome measures to describe practice patterns. The goal is to characterize how molecular data are being used in routine care and where gaps or inconsistencies remain.
Who should consider this trial
Good fit: The focus is on patients with newly diagnosed, uterine‑confined (FIGO 2009/2023 stage I–II) endometrial cancer treated at participating Italian surgical centers.
Not a fit: Patients with advanced (stage III–IV) disease, those treated outside participating centers, or patients at sites that do not perform molecular testing are unlikely to benefit directly from this project's findings.
Why it matters
Potential benefit: If successful, this could reduce unnecessary adjuvant treatment for low‑risk molecular groups (especially POLE‑mutated tumors) and better target therapy to higher‑risk molecular profiles.
How similar studies have performed: Large genomic efforts (TCGA) and numerous validation cohorts and prospective trials have consistently shown that molecular classification (POLE, MMRd/MSI, p53, NSMP) provides strong prognostic information.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. be Italian healthcare hospitals that are involved in the treatment of endometrial carcinoma, 2. involved in the surgical management of EC. Exclusion Criteria: a) declining to participate.
Where this trial is running
Roma, Roma
- Fondazione Policlinico Universitario Agostino Gemelli, IRCCS — Roma, Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Camilla Nero — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Camilla Nero CN Camilla Nero, PhD
- Email: camilla.nero@policlinicogemelli.it
- Phone: 0630157104
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.