HUmanitas PROtontherapy (HU-PRO)

NCT07317245 | Recruiting

• 1 other identifier: PRO/OSS - 001/2026
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Proton therapy is a cancer treatment, similar to the more commonly used radiation therapy. It uses radiation to destroy cancer cells and helps control the disease in the treated area. However, when proton therapy is compared with standard radiation therapy, many studies show fewer side effects and better disease control. This is due to the unique physical properties of the particles used in proton therapy. At present, in Italy, this innovative treatment is available only for selected diseases, as defined by national guidelines. For this reason, it is very important to collect as much data as possible to support the further development of proton therapy and to improve treatment safety and effectiveness.

Conditions

Cancer; Proton Therapy

Keywords

registry; cancer; proton therapy; re-irradiation

Outcome Measures

Primary Outcomes (1)

• collecting real world data

  To collect real-world data on cancer patients treated with protonherapy, to support research and to provide evidence of the role of protontherapy in a multidisciplinary approach.

  from enrollment to 10 years

Secondary Outcomes (7)

• toxicities profiles

  from enrollment to 10 years

• identify prognostic biomarkers

  from enrollment to 10 years

• Optimize treatment plannig

  from enrollment to 10 years

• Secondary Cancer Risk

  from enrollment to 10 years

• Asses Outcomes in Rare or Radioresistant Tumors

  from enrollment to 10 years

Study Arms (1)

proton therapy

all patients treated with proton therapy according to clinical practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with indication to proton therapy treatment

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years old
• ECOG (performance status scale) \>3
• Life expectancy \< 3 months
• Inability to provide informed consent

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

IRCCS Humanitas Research Hospital

Rozzano, Michigan, 20025, Italy

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Marta Scorsetti, MD, radiation oncologist

CONTACT

+39 0282248524; marta.scorsetti@hunimed.eu

Davide Franceschini, MD, radiation oncologist

CONTACT

+39 0282247428; davide.franceschini@cancercenter.humanitas.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 5, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2036
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

IT (1)