Humanitas Proton Therapy (HU-PRO) Registry
HUmanitas PROtontherapy (HU-PRO)
Istituto Clinico Humanitas · NCT07317245
This registry collects treatment and outcome data from adults with solid tumors who receive proton therapy to help understand safety and effectiveness.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Rozzano, Michigan) |
| Trial ID | NCT07317245 on ClinicalTrials.gov |
What this trial studies
HU-PRO is an observational registry run by Istituto Clinico Humanitas that gathers clinical, treatment, toxicity, and outcome data on adult patients treated with proton therapy. Enrollment targets patients eligible for proton therapy under Italian national guidelines, including selected indications and re-irradiation cases. The registry records performance status, treatment parameters, side effects, and disease control during follow-up to build real-world evidence. Collected data are intended to support broader development, optimize patient selection, and improve treatment safety and effectiveness.
Who should consider this trial
Good fit: Adults (≥18 years) with solid tumors who have an indication for proton therapy according to Italian regulations, with ECOG performance status 0–2 and able to provide informed consent are ideal candidates.
Not a fit: Patients under 18, those with ECOG >3, life expectancy under three months, or those unable to consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the registry could improve understanding of who benefits most from proton therapy and help make treatment safer and more accessible.
How similar studies have performed: Many prior studies comparing proton and conventional radiation report fewer side effects and improved local control for certain cancers, though results vary by tumor type and more real-world data are still needed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Solid tumors candidate to proton therapy, in particular, according to Italian regolamentations * Written informed consent for HU-PRO according to applicable legal and ethical requirements * Indication for proton therapy * ≥ 18 years old * ECOG PS (performance status scale) 0-2 Exclusion Criteria: * Age \< 18 years old * ECOG (performance status scale) \>3 * Life expectancy \< 3 months * Inability to provide informed consent
Where this trial is running
Rozzano, Michigan
- IRCCS Humanitas Research Hospital — Rozzano, Michigan, Italy (RECRUITING)
Study contacts
- Study coordinator: Marta Scorsetti, MD, radiation oncologist
- Email: marta.scorsetti@hunimed.eu
- Phone: +39 0282248524
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.
Conditions: Cancer, Proton Therapy, registry, cancer, proton therapy, re-irradiation