Clinical trial NCT05203250: Longitudinal Registry Including Patients Treated With Heavy Particles
Official title: CNAO REgistry triAL - REGAL
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Oncology
Radiation Exposure
Radiotherapy Side Effect
Radiation Toxicity
Rare Disease
Keywords: Hadrontherapy
Oncology
Cancer
Radiotherapy
Protons
Carbon Ions
Heavy ions
Rare cancer
Lead sponsor: CNAO National Center of Oncological Hadrontherapy
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated with particle therapy, protons and/or carbon ions, at the National Center for Oncological Hadrontherapy (CNAO), based in Pavia, who have signed the written informed consent document, can be enrolled in the study

Brief summary: The purpose of this registry is to collect retrospective and prospective standardized data of patients treated with particle therapy, either with protons or carbon ions, at the National Center for Oncological Hadrontherapy (CNAO) based in Pavia.

By keeping track of the patients treated, it will allow the investigators to periodically analyze and evaluate data collected of daily clinical activity. This will help gathering more information on the results of particle therapy and will provide the basis for in depth evaluation of patients' outcome with respect to the delivered treatment.

Detailed description: Hadrontherapy is a unique radiotherapy (RT) that uses positively charged particles, namely protons and carbons, rather than photons used in conventional RT, to treat cancer.

Particle therapy represents a coming together of physics research applied to oncology and it is currently the most advanced form of radiotherapy for the treatment of tumors that are particularly radio resistant or located nearby sensitive structures.The strength of hadrontherapy lies in the unique physical and radiobiological properties of these particles. Indeed, protons and carbon ions have several biological advantages compared to conventional photon radiotherapy.

In this scenario we aim at constructing a patient registry to retrospectively and prospectively collect real-world data on all cancer patients treated at CNAO, either with protons or carbon ion radiation, independently of their disease (multiple cohorts will be included) for which they were treated.

We aim at collecting data on the natural history of the disease (how the disease presents, develops and progress, its association with other conditions). Those data will allow us to assess prognostic and predictive factors to evaluate treatment effects and toxicities and to provide evidence of the role of radiation oncology in a multidisciplinary approach.

Such registry will be used to generate clinical evidence and high-quality data that could better define the indications for heavy particles therapy and become a resource for the wider scientific community.

Eligibility criteria: Inclusion Criteria:

* Patients treated with heavy particles at Fondazione CNAO, Pavia
* Patients who have the ability to understand and be willing to sign a written informed consent document

Exclusion Criteria:

* Patients or legal guardians who are unable to understand informed consent document

Primary outcomes:
measure: Real world data collection
timeFrame: 50 years
Secondary outcomes:
measure: Disease evolution
timeFrame: 50 years
measure: Predicitive models
timeFrame: 50 years
measure: Outcome data
timeFrame: 50 years
measure: Toxicities
timeFrame: 50 years
measure: QoL
timeFrame: 50 years
measure: Future research
timeFrame: 50 years
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: National Center for Oncological Hadrontherapy (CNAO)
Study officials:
References:
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