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Trial Title:
Advanced Proton Therapy Approaches: a Multicenter High-quality Data Registry
NCT ID:
NCT05860361
Condition:
Cancer
Conditions: Keywords:
proton therapy
registry
high-quality dataset
prospective data collection
hypofractionation
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
The aim of the present registry is to prospectively collect data on patients treated with
protontherapy in order to improve knowledge on indication, feasibility, and clinical
results of hypofractionated schedules applied in the setting of patients.
Detailed description:
Paucity and low evidence level data on protontherapy (PT) represent one of the main
issues for the establishment of solid indications in the PT setting. Aim of the present
registry is to provide a tool for systematic, prospective, harmonized, and
multidimensional high-quality data collection to promote knowledge in the field of PT
with a particular focus on the use of hypofractionation.
All patients with any type of oncologic disease (benign and malignant disease) who will
be eligible for PT at the European Institute of Oncology (IEO), will be included in the
present registry. Three levels of data collection will be implemented: Level 1 clinical
research (patients outcome and toxicity, quality of life, and cost/effectiveness
analysis); Level 2 radiological research (radiomic and dosiomic analysis, as well as
biological modeling); Level 3 Biological and Translational research (biological
biomarkers and genomic data analysis).
Endpoints and outcome measures of hypofractionation schedules will be evaluated in terms
of either Treatment Efficacy (tumor response rate, time to progression/percentages of
survivors/median survival, clinical, biological, and radiological biomarkers changes,
identified as surrogate endpoints of cancer survival/response to treatment) and Toxicity.
The study protocol has been approved by the IEO ethical committee (IEO 1885). Other than
patients treated at IEO, additional PT facilities (equipped with IBA Proteus®ONE or
Proteus®PLUS technologies) are planned to join the registry data collection. Moreover,
the registry will be also fully integrated into international PT data collection
networks.
Criteria for eligibility:
Study pop:
All patients aged >= 18 years with any type of oncologic disease (benign and malignant
disease) eligible for proton therapy and able to provide informed consent (themselves, or
through a designated legal guardian) to the registry.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion criteria:
- diagnosis of oncological disease (benign and malignant disease);
- candidates to proton therapy;
- able to provide informed consent.
Exclusion criteria:
- age < 18 years.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
European Institute of Oncology
Address:
City:
Milan
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Daniela Alterio
Start date:
April 14, 2023
Completion date:
October 1, 2030
Lead sponsor:
Agency:
European Institute of Oncology
Agency class:
Other
Source:
European Institute of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05860361
