Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorIstituto Clinico Humanitas
Academic / other
Drugs / interventionsradiation
Locations1 site (Rozzano, Michigan)
StatusRecruiting
StartedJanuary 12, 2026
Main results expectedJanuary 2036
Study endsJanuary 2036
Registry record updatedJanuary 21, 2026
Trial IDNCT07317245 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.