Ignite Creation Date:
2025-12-17 @ 1:42 PM
Ignite Modification Date:
2025-12-21 @ 9:10 PM
Study NCT ID:
NCT05860361
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2023-04-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Advanced Proton Therapy Approaches: a Multicenter High-quality Data Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and saliva samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2030-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2023-04-07', 'studyFirstSubmitQcDate': '2023-05-05', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Efficacy: tumor response rate', 'timeFrame': '10 years', 'description': 'tumor response rate according to RECIST criteria'}, {'measure': 'Treatment Efficacy: % of tumor recurrence', 'timeFrame': '10 years', 'description': '% of tumor recurrence assessed by progression-free survival rate'}, {'measure': 'Treatment Efficacy: rate of death', 'timeFrame': '10 years', 'description': 'rate of death assessed by overall survival rates'}], 'secondaryOutcomes': [{'measure': 'Treatment Toxicity: incidence of acute and late toxicity', 'timeFrame': '10 years', 'description': 'incidence of acute and late toxicity collected according to CTCAE v. 6.0'}, {'measure': 'Treatment Toxicity: patients quality of life', 'timeFrame': '10 years', 'description': 'patients quality of life assessed by internationally validated EORTC questionnaires'}, {'measure': 'Treatment Toxicity: patients pain', 'timeFrame': '10 years', 'description': 'patients pain assessed by Visual Analog Score'}, {'measure': 'Treatment Toxicity: treatment costs', 'timeFrame': '10 years', 'description': 'treatment costs assessed with quality adjusted life years (QALY)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['proton therapy', 'registry', 'high-quality dataset', 'prospective data collection', 'hypofractionation'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAll 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).\n\nEndpoints 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* diagnosis of oncological disease (benign and malignant disease);\n* candidates to proton therapy;\n* able to provide informed consent.\n\nExclusion criteria:\n\n\\- age \\< 18 years.'}, 'identificationModule': {'nctId': 'NCT05860361', 'briefTitle': 'Advanced Proton Therapy Approaches: a Multicenter High-quality Data Registry', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'Advanced Proton Therapy Approaches: a Multicenter High-quality Data Registry', 'orgStudyIdInfo': {'id': 'R1760722-IEO 1885'}}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniela Alterio', 'role': 'CONTACT'}], 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Roberto Orecchia, Prof', 'role': 'CONTACT', 'email': 'roberto.orecchia@ieo.it', 'phone': '+39 0257489578'}, {'name': 'Daniela Alterio, MD', 'role': 'CONTACT', 'email': 'daniela.alterio@ieo.it', 'phone': '+39 0257489629'}], 'overallOfficials': [{'name': 'Roberto Orecchia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European Institute of Oncology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}