Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT05109858
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2021-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Skin Toxicity by Oncological Therapies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 334}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2021-09-16', 'studyFirstSubmitQcDate': '2021-10-25', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the type of skin toxicities related to oncological treatment', 'timeFrame': '5 years', 'description': 'Data will be described using absolute and (percentage) relative frequencies calculated for specific types of skin toxicities collected by the participating centers. Specific types of skin toxicities will be defined during dermatologists involved in the study, based on subjects enrolled at each site.'}, {'measure': 'Evaluation of the frequency of skin toxicities related to oncological treatment', 'timeFrame': '5 years', 'description': 'Absolute and (percentage) relative frequencies will be calculated for skin toxicities, stratified considering different oncological treatments.'}, {'measure': 'Evaluation of the severity of skin toxicities related to oncological treatment', 'timeFrame': '5 years', 'description': 'Grade of severity of skin toxicities will be collected: absolute and (percentage) relative frequencies will be calculated for different grades of severity.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the association between skin toxicities and baseline clinical parameters', 'timeFrame': '5 years', 'description': 'A statistical model will be carried out, namely a mathematical relationship between presence of skin toxicities and baseline clinical parameter. Mathematical model will be a logistic regression, in which, independent variable is the presence of skin toxicities while dependent variables are parameters measured at baseline. These parameters could be continuous (for example: age of patients) or categorical (for example: gender or site of disease).'}, {'measure': 'Evaluation of the association between skin toxicities and objective response rate', 'timeFrame': '5 years', 'description': 'Statistical modelling of the association between skin toxicities and objective response rate (ORR) as drug effectiveness parameter. To analyze objective response rate (ORR), proportion of patients with complete and partial response will be calculated, globally for all patients and considering different subgroup of treatment type.'}, {'measure': 'Evaluation of the association between skin toxicities and progression-free survival', 'timeFrame': '5 years', 'description': 'Statistical modelling of the association between skin toxicities and progression-free survival (PFS) as drug effectiveness parameter. To evaluate progression-free survival, difference between date of start therapy and date of disease progression (or death) will be calculated.'}, {'measure': 'Evaluation of the association between skin toxicities and overall survival', 'timeFrame': '5 years', 'description': 'Statistical modelling of the association between skin toxicities and overall survival (OS) as drug effectiveness parameter. To evaluate overall survival, difference between date of start therapy and date of or death will be calculated. Time for patients without event (progression of disease or death) will be considered from date of start therapy and date of last contact.'}, {'measure': 'Evaluation of the optimal management of skin toxicities related to cancer treatment', 'timeFrame': '5 years', 'description': 'Data related to management of skin toxicities will be described using absolute and (percentage) relative frequencies calculated for specific types of skin toxicities collected by the participating centers.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['skin toxicities', 'oncological therapies'], 'conditions': ['Skin Toxicity']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, retrospective and prospective observational study. The project involves the collection of clinical data of patients treated with oncological therapies, to evaluate skin toxicities related to oncological treatment.', 'detailedDescription': 'This is a multicenter, retrospective and prospective observational study. The research will include 300 patients treated with clinical practice oncological treatments (approved by Italian Competent Authority, AIFA) from January 2012 to February 2024.\n\nPatients will follow the prescribed therapeutic indications according to regular clinical practice and data from their medical records will be collected in a study database.\n\nPrimary objective of the study is the evaluation of the type, frequency and severity of skin toxicities related to oncological treatment.\n\nSecondary objectives are:\n\n* Evaluation of the association between skin toxicities due to oncological treatment and drug activity and effectiveness parameters(ORR, PFS, OS);\n* Evaluation of the association between clinical-pathological features of primary cancer and skin toxicities of oncological treatment;\n* Evaluation of the optimal management of skin toxicities related to cancer treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with any oncological therapy (approved by AIFA) as per clinical practice, from 2012 to 2024.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient who have signed informed consent.\n2. Consecutive retrospective patients and prospective patients treated with new clinical practice oncological treatments (approved by AIFA) from January 2012 to February 2024\n3. Male or female, age ≥18 years.\n\nExclusion Criteria:\n\nParticipation in another clinical trial with any investigational drug.'}, 'identificationModule': {'nctId': 'NCT05109858', 'acronym': 'SKINTOX', 'briefTitle': 'Skin Toxicity by Oncological Therapies', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS'}, 'officialTitle': 'Observational Study on Skin Toxicity by Oncological Therapies', 'orgStudyIdInfo': {'id': 'IRST100.41'}}, 'contactsLocationsModule': {'locations': [{'zip': '39012', 'city': 'Merano', 'state': 'Bolzano', 'country': 'Italy', 'facility': 'Ospedale "Franz Tappeiner"', 'geoPoint': {'lat': 46.66817, 'lon': 11.15953}}, {'zip': '47521', 'city': 'Cesena', 'state': 'Forlì-Cesena', 'country': 'Italy', 'facility': 'AUSL della Romagna - Ospedale "M. Bufalini"', 'geoPoint': {'lat': 44.1391, 'lon': 12.24315}}, {'zip': '47014', 'city': 'Meldola', 'state': 'Forlì-Cesena', 'country': 'Italy', 'facility': 'IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'zip': '04019', 'city': 'Terracina', 'state': 'Latina', 'country': 'Italy', 'facility': 'Sapienza Università di Roma - Polo Pontino', 'geoPoint': {'lat': 41.29174, 'lon': 13.24359}}, {'zip': '33081', 'city': 'Aviano', 'state': 'Pordenone', 'country': 'Italy', 'facility': 'Centro di Riferimento Oncologico', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'IRCCS Istituto Tumori "Giovanni Paolo II"', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Università di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '66100', 'city': 'Chieti', 'country': 'Italy', 'facility': 'Università "G. D\'Annunzio"', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'zip': '50125', 'city': 'Florence', 'country': 'Italy', 'facility': 'Azienda USL Toscana Centro', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '03100', 'city': 'Frosinone', 'country': 'Italy', 'facility': 'ASL di Frosinone - Ospedale "Fabrizio Spaziani"', 'geoPoint': {'lat': 41.63976, 'lon': 13.34109}}, {'zip': '98158', 'city': 'Messina', 'country': 'Italy', 'facility': 'Azienda Ospedaliera "Papardo"', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Istituto Nazionale dei Tumori', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Europe di Oncologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale"', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Università della Campania "Luigi Vanvitelli"', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '00128', 'city': 'Roma', 'country': 'Italy', 'facility': 'Università Campus Bio-Medico', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '84131', 'city': 'Salerno', 'country': 'Italy', 'facility': "Università degli Studi di Salerno AOU san Giovanni di Dio e Ruggi D'Aragona", 'geoPoint': {'lat': 40.67545, 'lon': 14.79328}}, {'zip': '53100', 'city': 'Siena', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Senese', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'zip': '10026', 'city': 'Torino', 'country': 'Italy', 'facility': 'AOU Città della Salute e della Scienza', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Matelda Medri, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'IRST IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}