An observational study in Cancer and Proton Therapy, sponsored by Istituto Clinico Humanitas. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Istituto Clinico Humanitas · Observational
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 500 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Istituto Clinico Humanitas is the lead sponsor of 275 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with indication to proton therapy treatment
Exclusion Criteria:
all patients treated with proton therapy according to clinical practice
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.
Time frame: from enrollment to 10 years
toxicities profiles
Asses acute and late onset side effects and compare toxicity rates with conventional radiotherapy (toxicity classification by CTCAE)
Time frame: from enrollment to 10 years
identify prognostic biomarkers
Investigate biological and clinical factors that influence treatment response and survival (blood samples and saliva samples for Head\&Neck patients)
Time frame: from enrollment to 10 years
Optimize treatment plannig
Asses different proton therapy techniques and procedures to refine clinical practice (Radiotherapy plans comparison)
Time frame: from enrollment to 10 years
Secondary Cancer Risk
Monitoring long term cancer incidence in patients treated with proton therapy, especially in young patients (clinical data comparison - appearance of disease after treatment)
Time frame: from enrollment to 10 years
Asses Outcomes in Rare or Radioresistant Tumors
Collect data on tumor types with limited evidence to determine optimal indications for proton therapy (clinical data comparison)
Time frame: from enrollment to 10 years
Monitor Treatment Adherence and Compliance
Evaluate factors influencing patient adherence to treatment schedules and follow up care
Time frame: from enrollment to 10 years
Analyze Quality of Life Outcomes
Measure patient reported outcomes (PROs) to understand the impact of proton therapy on daily life and well being (QLQ-C30 and different questionnaries according to pathology site)
Time frame: from enrollment to 10 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Istituto Clinico Humanitas