Advanced Proton Therapy Approaches: a Multicenter High-quality Data Registry
NCT ID: NCT05860361
Last Updated: 2024-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2023-04-14
2030-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* candidates to proton therapy;
* able to provide informed consent.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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European Institute of Oncology
OTHER
Responsible Party
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Principal Investigators
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Roberto Orecchia
Role: PRINCIPAL_INVESTIGATOR
European Institute of Oncology
Locations
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European Institute of Oncology
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Daniela Alterio
Role: primary
Other Identifiers
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R1760722-IEO 1885
Identifier Type: -
Identifier Source: org_study_id
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