Humanitas Proton Therapy (HU-PRO) Registry
Official title: HUmanitas PROtontherapy (HU-PRO)
Run by Istituto Clinico Humanitas · NCT07317245 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rozzano, Michigan) |
| Status | Recruiting |
| Started | January 12, 2026 |
| Main results expected | January 2036 |
| Study ends | January 2036 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT07317245 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.