Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-01-06 @ 7:58 PM
Study NCT ID:
NCT06270602
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2024-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The ONCOCAMP Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D012189', 'term': 'Retrospective Studies'}, {'id': 'D008137', 'term': 'Longitudinal Studies'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D016022', 'term': 'Case-Control Studies'}, {'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D015331', 'term': 'Cohort Studies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2024-01-29', 'studyFirstSubmitQcDate': '2024-02-13', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence for each tumor of the patients included in the ROC platform', 'timeFrame': 'Every year up to 5 years', 'description': 'Incidence for each tumor of the patients included in the ROC platform'}, {'measure': 'Evaluation of the time interval between GOM activities', 'timeFrame': 'Every 6 months up to 3 years', 'description': 'Time interval between reporting and taking charge by the GOM, the date diagnosis and the GOM meeting date, the first GOM meeting and the final therapeutic decision, the therapy decision and the therapeutic act, and the request for home assistance and the actual taking in charge by the ASL'}, {'measure': 'Evaluation of the time interval between GOM activities', 'timeFrame': 'Every 6 months up to 3 years', 'description': 'Time interval between the request for home assistance and the actual taking in charge by the ASL'}, {'measure': 'Evaluation of the time interval between GOM activities', 'timeFrame': 'Every 6 months up to 3 years', 'description': 'Time interval between the therapy decision and the therapeutic act'}, {'measure': 'Evaluation of the time interval between GOM activities', 'timeFrame': 'Every 6 months up to 3 years', 'description': 'Time interval between the first GOM meeting and the final therapeutic decision'}, {'measure': 'Evaluation of the time interval between GOM activities', 'timeFrame': 'Every 6 months up to 3 years', 'description': 'Time interval betweenthe date diagnosis and the GOM meeting date'}, {'measure': 'Frequency of use of the services of the ROC platform', 'timeFrame': 'Every 2 months up to 5 years', 'description': 'Frequency of use of the services of the ROC platform'}, {'measure': 'Descriptive analysis of each subgroup of patients (subdivision by tumor type)', 'timeFrame': 'Every 6 months up to 5 years', 'description': 'Descriptive analysis of each subgroup of patients (subdivision by tumor type)'}, {'measure': 'Spatial analysis for each patient', 'timeFrame': 'Every year up to 5 years', 'description': 'Spatial analysis for each patient'}, {'measure': 'Frequency of adherence to guidelines of the Diagnostic Therapeutic Assistance Paths (PDTA)', 'timeFrame': 'Every 6 months up to 5 years', 'description': 'Frequency of adherence to guidelines of the Diagnostic Therapeutic Assistance Paths (PDTA)'}, {'measure': 'Percentage of patient included in clinical trial', 'timeFrame': 'Every 2 months up to 5 years', 'description': 'Percentage of patient included in clinical trial'}, {'measure': 'Assessment of costs arising due to inefficiencies (repetition and inappropriateness of diagnostic tests; passive health mobility rate', 'timeFrame': 'Every 6 months up to 5 years', 'description': 'Assessment of costs arising due to inefficiencies (repetition and inappropriateness of diagnostic tests; passive health mobility rate'}, {'measure': 'Prevalence for each tumor of the patients included in the ROC platform', 'timeFrame': 'Every year up to 5 years', 'description': 'Prevalence for each tumor of the patients included in the ROC platform'}], 'secondaryOutcomes': [{'measure': 'Description of pharmacological strategies', 'timeFrame': 'Every year up to 5 years', 'description': 'Evaluation of pharmacological strategies'}, {'measure': 'Description of diagnostic activities', 'timeFrame': 'Every year up to 5 years', 'description': 'Evaluation of diagnostic activities'}, {'measure': 'Description of surgical strategies', 'timeFrame': 'Every year up to 5 years', 'description': 'Evaluation of surgical strategies'}, {'measure': 'Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA)', 'timeFrame': 'Every 6 months up to 5 years', 'description': 'Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA)'}, {'measure': 'Description of each surgical approach', 'timeFrame': 'Every year up to 5 years', 'description': 'Description of each surgical approach'}, {'measure': 'Description of the different surgical techniques among the centers', 'timeFrame': 'Every year up to 5 years', 'description': 'Description of the different surgical techniques among the centers'}, {'measure': "Patients' quality of life", 'timeFrame': 'Every year up to 5 years', 'description': "Patients' quality of life using questionnaires"}, {'measure': "Patients' reported outcome", 'timeFrame': 'Every year up to 5 years', 'description': "Patients' reported outcome using questionnaires"}, {'measure': "Patients' satisfaction and evaluation of the diagnostic / therapeutic path", 'timeFrame': 'Every year up to 5 years', 'description': "Patients' satisfaction and evaluation of the diagnostic / therapeutic path using questionnaires"}, {'measure': 'Correlation analysis among risk factors and diagnostic / therapeutic delay or poor prognosis', 'timeFrame': 'Every year up to 5 years', 'description': 'Correlation analysis among risk factors and diagnostic / therapeutic delay or poor prognosis'}, {'measure': 'Dependence analysis between the conditions of social deprivation of ROC patients and the time to the first GOM visit', 'timeFrame': 'Every year up to 5 years', 'description': 'Dependence analysis between the conditions of social deprivation of ROC patients and the time to the first GOM visit'}, {'measure': 'Dependence analysis among costs, socio-demographic characteristics and some variables related to the diagnostic / therapeutic path', 'timeFrame': 'Every year up to 5 years', 'description': 'Dependence analysis among costs, socio-demographic characteristics and some variables related to the diagnostic / therapeutic path'}, {'measure': 'Survival analysis for each tumor', 'timeFrame': 'Every 2 years up to 6 years', 'description': 'Survival analysis for each tumor'}, {'measure': 'Life status assessment for each patient', 'timeFrame': 'Every year up to 5 years', 'description': 'Life status assessment for each patient'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oncological Network', 'Multidisciplinary Oncology Groups'], 'conditions': ['Oncology']}, 'referencesModule': {'references': [{'pmid': '40284239', 'type': 'DERIVED', 'citation': "Porciello G, Di Lauro T, Luongo A, Coluccia S, Prete M, Abbadessa L, Coppola E, Di Martino A, Mozzillo AL, Racca E, Piccirillo A, Di Giacomo V, Fontana M, D'Amico M, Palumbo E, Vitale S, D'Errico D, Turra V, Parascandolo I, Stallone T, Augustin LSA, Crispo A, Celentano E, Pignata S. Optimizing Nutritional Care with Machine Learning: Identifying Sarcopenia Risk Through Body Composition Parameters in Cancer Patients-Insights from the NUTritional and Sarcopenia RIsk SCREENing Project (NUTRISCREEN). Nutrients. 2025 Apr 18;17(8):1376. doi: 10.3390/nu17081376."}]}, 'descriptionModule': {'briefSummary': 'The present study is a retrospective-prospective observational and multicentric study aiming to collect data relating to all patients included in the ROC platform. All ROC centers will be involved in the present study.', 'detailedDescription': 'The ROC platform therefore represents a multicenter database and a growing source of data and information regarding cancer patients in the Campania region. The need for multicenter databases is supported by the results obtained with both retrospective and prospective studies. Many retrospective studies have led to changes in some of the available guidelines. Important advantages of this study include representativeness of the analyzed cohort to all patients with a specific cancer and a large sample size that provides sufficient statistical power to detect differences across different patient groups. The data extracted from the ROC have the potential to produce knowledge, to guide decision-making, and to manage more effectively the challenges of fighting cancer in our region. The Campania region counts more than 6 million people, and it is characterized by a worst oncological outcome compared to the average data of other Italian region: the ROC platform has the potential to analyze the effect of a public intervention in the field of oncology care. Therefore, the primary aim of this study is to create a retrospective-prospective registry of all cancer patients entering the ROC platform and in a GOM path describing the primary and secondary endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. All consecutive patients entered in the ROC platform from the start of platform activation (November 2018) until the date in which the study is approved by the local ethical committee (The retrospective cohort will be made by more than 40000 patients already included in the platform and entered a GOM path.\n2. All consecutive patients who enter in the ROC platform as for clinical practice from the date in which the study is approved by the local ethical committee (Investigator is allowed to enroll patients).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed informed consent\n* registration in the ROC platform'}, 'identificationModule': {'nctId': 'NCT06270602', 'briefTitle': 'The ONCOCAMP Study', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Naples'}, 'officialTitle': 'A Retrospective-prospective, Observational, Multicentric Study to Record Data From the ROC Platform and Monitor the ROC Performance', 'orgStudyIdInfo': {'id': 'ONCOCAMP'}, 'secondaryIdInfos': [{'id': '6/23 oss', 'type': 'OTHER', 'domain': 'IRCCS I.N.T. "G. Pascale"'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A (Retrospective):', 'description': 'All consecutive patients entered in the ROC platform from the start of platform activation (November 2018) until the date in which the study is approved by the local ethical committee (Investigator is allowed to enroll patients) will be enrolled. The retrospective cohort will be made by more than 40000 patients already included in the platform and entered a GOM path', 'interventionNames': ['Other: Data collection (retrospective)']}, {'label': 'Cohort B (Prospective):', 'description': 'All consecutive patients who enter in the ROC platform as for clinical practice from the date in which the study is approved by the local ethical committee (Investigator is allowed to enroll patients).', 'interventionNames': ['Other: Data collection (prospective)']}], 'interventions': [{'name': 'Data collection (retrospective)', 'type': 'OTHER', 'description': 'Collection of patient data entered in the ROC platform from the beginning activation of the platform (November 2018) until the date on which the study is approved by the local ethics committee', 'armGroupLabels': ['Cohort A (Retrospective):']}, {'name': 'Data collection (prospective)', 'type': 'OTHER', 'description': 'Collection of patient data entered in the ROC platform from the date in which the study is approved by the local ethical committee', 'armGroupLabels': ['Cohort B (Prospective):']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83100', 'city': 'Avellino', 'state': 'Avellino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cesare Gridelli, M.D.', 'role': 'CONTACT'}], 'facility': 'A.O. Moscati', 'geoPoint': {'lat': 40.91494, 'lon': 14.79103}}, {'zip': '83100', 'city': 'Avellino', 'state': 'Avellino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Genua, M.D.', 'role': 'CONTACT'}], 'facility': 'Asl Avellino', 'geoPoint': {'lat': 40.91494, 'lon': 14.79103}}, {'zip': '82100', 'city': 'Benevento', 'state': 'Benevento', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Grimaldi, M.D.', 'role': 'CONTACT'}], 'facility': 'A.O. Rummo', 'geoPoint': {'lat': 41.1307, 'lon': 14.77816}}, {'zip': '82100', 'city': 'Benevento', 'state': 'Benevento', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elena Fossi, M.D.', 'role': 'CONTACT'}], 'facility': 'Asl Benevento', 'geoPoint': {'lat': 41.1307, 'lon': 14.77816}}, {'zip': '81035', 'city': 'Caserta', 'state': 'Caserta', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonella Guida, M.D.', 'role': 'CONTACT'}], 'facility': 'Asl Caserta', 'geoPoint': {'lat': 41.07262, 'lon': 14.33231}}, {'zip': '81100', 'city': 'Caserta', 'state': 'Caserta', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michele Orditura, M.D.', 'role': 'CONTACT'}], 'facility': 'A.O. S.Anna S. Sebastiano', 'geoPoint': {'lat': 41.07262, 'lon': 14.33231}}, {'zip': '80020', 'city': 'Casavatore', 'state': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Filomena Sibilio, M.D.', 'role': 'CONTACT'}], 'facility': 'Asl Napoli 2 Nord', 'geoPoint': {'lat': 40.89921, 'lon': 14.27663}}, {'zip': '80056', 'city': 'Ercolano', 'state': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mario Fusco, M.D.', 'role': 'CONTACT'}], 'facility': 'Asl Napoli 3 Sud', 'geoPoint': {'lat': 40.80783, 'lon': 14.35012}}, {'zip': '80131', 'city': 'Napoli', 'state': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ferdinando Riccardi, M.D.', 'role': 'CONTACT'}], 'facility': 'A.O. Cardarelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '80131', 'city': 'Napoli', 'state': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Montesarchio, M.D.', 'role': 'CONTACT'}], 'facility': 'A.O. Dei Colli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '80131', 'city': 'Napoli', 'state': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sabino De Placido, M.D.', 'role': 'CONTACT'}], 'facility': 'Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '80131', 'city': 'Napoli', 'state': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sandro Pignata, M.D.', 'role': 'CONTACT'}], 'facility': 'I.N.T. Pascale', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '80138', 'city': 'Napoli', 'state': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fortunato Ciardiello, M.D.', 'role': 'CONTACT'}], 'facility': 'A.O.U. Luigi Vanvitelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '80145', 'city': 'Napoli', 'state': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Tiziana Spinosa, M.D.', 'role': 'CONTACT'}], 'facility': 'Asl Napoli 1 Centro', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '80147', 'city': 'Napoli', 'state': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Bruno Daniele, M.D.', 'role': 'CONTACT'}], 'facility': 'Ospedale del Mare', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '84124', 'city': 'Salerno', 'state': 'Salerno', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Di Lorenzo, M.D.', 'role': 'CONTACT'}], 'facility': 'Asl Salerno', 'geoPoint': {'lat': 40.67545, 'lon': 14.79328}}, {'zip': '84126', 'city': 'Salerno', 'state': 'Salerno', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano Pepe, M.D.', 'role': 'CONTACT'}], 'facility': 'A.O.U. Ruggi', 'geoPoint': {'lat': 40.67545, 'lon': 14.79328}}], 'centralContacts': [{'name': 'Sandro Pignata, M.D.', 'role': 'CONTACT', 'email': 's.pignata@istitutotumori.na.it', 'phone': '08117770755'}], 'overallOfficials': [{'name': 'Sandro Pignata, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS I.N.T. "G. Pascale"'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Naples', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}