National registry of endometrial cancer cases in Italy
The ENDOCancer-DATA: the Surveillance, Epidemiology, and End Results Database Program on Endometrial Cancer in the Italian Population
This project will collect clinical and molecular information from adults treated for endometrial cancer at participating Italian oncology centers to see if a national database can improve understanding of outcomes and care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT07558889 on ClinicalTrials.gov |
What this trial studies
This observational program will create a centralized, systematic archive of epidemiological, clinical, surgical, pathological, and molecular (IHC and/or NGS) data for patients diagnosed with endometrial cancer at participating Italian reference centers. Data capture will include stage, grade, histotype, treatment details (including surgical approach), and follow-up outcomes to allow retrospective and future prospective analyses. The protocol emphasizes rigorous, continuous data recording modeled on registries like SEER to enable quality-control and longitudinal monitoring. Collected data will be used to describe population-level patterns, correlate molecular profiles with treatments and outcomes, and identify areas for improvement in national care pathways.
Who should consider this trial
Good fit: Adults (age >18) with histologically confirmed endometrial cancer (any stage or histotype) treated at participating centers who have IHC and/or NGS molecular profiling available and can provide informed consent.
Not a fit: Patients with missing or unrecoverable molecular profiles or those treated outside participating centers with only partial records are unlikely to benefit from inclusion in the database.
Why it matters
Potential benefit: If successful, the registry could provide national-level evidence on epidemiology, molecular subtypes, treatment patterns, and outcomes that help refine guidelines and personalize care for people with endometrial cancer.
How similar studies have performed: Large cancer registries such as the US SEER program have successfully supported epidemiologic and outcomes research, while comprehensive nationwide endometrial cancer registries are less common, making this a largely novel national effort in Italy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of endometrial cancer (stage I-IV, G1-3, and special histotypes) * age \> 18 years * American Society of Anesthesiologists classification (ASA score) 1-3 * patients undergoing staging, cytoreduction or diagnostic surgery with acquisition of histological examination on which IHC and/or NGS studies have been performed for the molecular profile of the carcinoma * Signed informed consent Exclusion Criteria: * patients with missing information * patients not treated in the participating centers for which only partial and fragmented information will be available * molecular profile not known and\\or not recoverable and retrospectively analysable
Where this trial is running
Roma
- Fondazione Policlinico Universitario Agostino Gemelli, IRCCS — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Francesco Fanfani — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Francesco Fanfani, MD
- Email: francesco.fanfani@policlinicogemelli.it
- Phone: +390630133421
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.