Actively Recruiting
HUmanitas PROtontherapy (HU-PRO)
Led by Istituto Clinico Humanitas · Updated on 2026-01-21
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Proton therapy is a cancer treatment similar to standard radiation therapy but uses unique particles that may reduce side effects and improve disease control. This trial focuses on collecting data to support the development and safety of proton therapy, which is currently available only for select diseases in Italy following national guidelines. The study is observational and aims to gather real-world information over an extended period. Participants in this study will receive proton therapy as part of their clinical care based on medical indications. The therapy is administered according to standard practice without experimental modifications. This study does not compare proton therapy to other treatments but observes outcomes from patients treated with this method. During the study, researchers will collect data from enrollment through 10 years, monitoring treatment side effects, identifying biomarkers, optimizing treatment planning, assessing secondary cancer risks, and evaluating quality of life. Participants will be followed long term to observe treatment adherence, outcomes in rare tumors, and overall safety. The total participation time may extend up to 10 years for comprehensive data collection.
CONDITIONS
Brief Title
HUmanitas PROtontherapy (HU-PRO)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years old or older
- Diagnosed with solid tumors eligible for proton therapy according to Italian regulations
- Have a performance status (ECOG) between 0 and 2
- Provided written informed consent for participation
- Indicated for proton therapy by a medical professional
You will not qualify if you...
- Younger than 18 years old
- Performance status (ECOG) greater than 3
- Life expectancy less than 3 months
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 10 years
Participants who undergo routine proton therapy are observed to collect real-world data and assess outcomes over time.
Regular visits aligned with clinical proton therapy and follow-up care
Trial Site Locations
Total: 1 location
1
IRCCS Humanitas Research Hospital
Rozzano, Michigan, Italy, 20025
Actively Recruiting
Research Team
M
Marta Scorsetti, MD, radiation oncologist
D
Davide Franceschini, MD, radiation oncologist
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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