Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-27 @ 5:46 AM
Study NCT ID:
NCT06822959
Status:
RECRUITING
Last Update Posted:
2025-02-18
First Post:
2025-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacogenetics, Therapeutic Drug Monitoring (TDM) and Active Pharmacovigilance as Innovative Tools Aimed at the Optimisation/ Appropriateness of Drug Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071185', 'term': 'Pharmacogenomic Testing'}], 'ancestors': [{'id': 'D005820', 'term': 'Genetic Testing'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-07', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients treated with study drugs tested with pharmacogenetic and TDM analysis', 'timeFrame': 'Up to 2 years', 'description': 'Percentage of patients treated with study drugs tested with pharmacogenetic and TDM analysis on total patients treated'}, {'measure': 'MedReview reports', 'timeFrame': 'Up to 2 years', 'description': 'Number of MedReview reports'}, {'measure': 'ADRs in patients treated on the basis of pharmacogenetics, TDM and MedReview', 'timeFrame': 'Up to 2 years', 'description': 'Incidence of ADRs in the study cohorts'}, {'measure': 'Comparison of ADRs in patients treated on the basis of pharmacogenetics, TDM and MedReview and retrospective data', 'timeFrame': 'Up to 2 years', 'description': 'Difference in incidence of ADRs in the prospective cohort will be tested against historical data with binomial test'}], 'secondaryOutcomes': [{'measure': 'Integration of pharmacogenetics, TDM and MedReview information in the existing tool for the evaluation of "Causality assessment" between ADR and specific drug', 'timeFrame': 'Up to 2 years', 'description': 'Change of Causality Assessment. The change is evaluated as the number of "definite" and "probable" associations between ADRs and suspected drugs compared with historical data'}, {'measure': 'Proposal for updating the pharmacovigilance reporting forms including Pharmacogenetics, TDM and MedReview information in the National Network of Pharmacovigilance', 'timeFrame': 'Up to 2 years', 'description': 'Frequencies of new reports sent to the National Pharmacovigilance Network, including pharmacogenetics, TDM, and drug interaction data'}, {'measure': 'European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 v3', 'timeFrame': 'Up to 2 years', 'description': 'The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients.\n\nThe possible answers to the questionnaire range from a minimum value ("not at all") to a maximum value ("very much"). Higher values indicate a worse quality of life.\n\nMean and standard deviation of scores at EORTC QLQ-C30 v3 questionnaire will be evaluated.'}, {'measure': 'Costs of ADRs management', 'timeFrame': 'Up to 2 years', 'description': 'Median and interquartile range of costs'}, {'measure': 'Concordance between plasmatic concentration measured with conventional methods and with new methods such as Dried Blood Spot (DBS)', 'timeFrame': 'Up to 2 years', 'description': "Lin's correlation coefficient between plasmatic concentration and DBS estimation"}, {'measure': 'Correlation between pharmacogenetic profile and drug exposure (TDM)', 'timeFrame': 'Up to 2 years', 'description': 'Difference in drug exposure measured as Cmin for different pharmacogenetic profiles'}, {'measure': 'Correlation between ADRs, TDM and pharmacogenetics analyses', 'timeFrame': 'Up to 2 years', 'description': 'Frequencies of ADRs in different subgroups of patients defined by TDM and pharmacogenetic profiles'}, {'measure': 'Correlation between ADRs, TDM and pharmacogenetics analyses', 'timeFrame': 'Up to 2 years', 'description': 'Frequencies of severe ADRs in different subgroups of patients defined by TDM and pharmacogenetic profiles'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adverse Drug Reaction (ADR)']}, 'descriptionModule': {'briefSummary': 'The primary goal of this observational study is to evaluate the feasibility of implementing a multidisciplinary approach based on pharmacogenetics, TDM (Therapeutic Drug Monitoring) and MedReview into the clinical practice in order to optimize the appropriateness of drugs prescription and to minimise the risk of Adverse Drug Reactions (ADRs) in adult cancer patients and in pediatric patients affected by chronic inflammatory diseases. This approach of active pharmacovigilance will also allow a better definition of the causality assessment of ADRs through the direct implementation of data quality in the reporting forms. The study may therefore constitute an example of an approach for both the prevention of ADRs and the optimization of drug use, and for the integration of pharmacogenetics, TDM, and the MedReview data into the National Pharmacovigilance Reports for an improved and innovative evaluation of adverse events, aiming at the implementation of this approach in the regional context.', 'detailedDescription': 'Primary aim of the study:\n\nTo implement the use of pharmacogenetics, TDM, and MedReview at the regional level supporting their utility through an observational approach to assess the effects of these innovative methods, already active in IRCCS, for the optimization of appropriate drug use and minimization of ADR risk in adult and pediatric oncology patients, as well as pediatric patients with chronic inflammatory diseases. Specifically, the aim is to evaluate the incidence of ADRs in patients treated based on pharmacogenetics, TDM, and MedReview compared to historical cases treated according to the standard of care before the implementation of the proposed innovative methodologies.\n\nSecondary aims of the study:\n\n1. To evaluate the "Causality Assessment" between ADR and drug based on the enhanced data quality deriving from the integration of pharmacogenetics, TDM and MedReview into the Pharmacovigilance report.\n2. To propose the systematic integration of the results related to pharmacogenetics, TDM, and MedReview within the existing fields of the current ADR reporting form. This aims to develop a proposal for updating AIFA procedures related to the inclusion of this type of evidence-based information in the National Pharmacovigilance Network (RNF), with a potential update of the reporting form.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are candidates for therapy with: Abemaciclib, Palbociclib, Ribociclib, Letrozole, Tamoxifen, Olaparib, Infliximab, Cyclophosphamide, Methotrexate, Irinotecan, Capecitabine, 5-Fluorouracil, Noraparib, Adalimumab, Imatinib, Regorafenib, Lenvatinib, Sorafenib, Sunitinib, Rucaparib, 6-MP/ Azathioprine', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients who are candidates for therapy with:\n\n* Abemaciclib,\n* Palbociclib,\n* Ribociclib,\n* Letrozole,\n* Tamoxifen,\n* Olaparib,\n* Niraparib,\n* Rucaparib,\n* Imatinib,\n* Sunitinib,\n* Sorafenib,\n* Regorafenib,\n* Lenvatinib,\n* Irinotecan,\n* Capecitabine,\n* 5-Fluorouracil,\n* Infliximab,\n* Cyclophosphamide,\n* Methotrexate,\n* Adalimumab,\n* 6-Mercaptopurine/Azathioprine'}, 'identificationModule': {'nctId': 'NCT06822959', 'briefTitle': 'Pharmacogenetics, Therapeutic Drug Monitoring (TDM) and Active Pharmacovigilance as Innovative Tools Aimed at the Optimisation/ Appropriateness of Drug Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Direzione centrale salute, politiche sociali e disabilità'}, 'officialTitle': 'Pharmacogenetics, Therapeutic Drug Monitoring (TDM) and Active Pharmacovigilance as Innovative Tools Aimed at the Optimisation/ Appropriateness of Drug Therapy and the Minimisation of the Risks of ADRs in Clinical Practice: a Multidisciplinary Approach Exportable at National Level', 'orgStudyIdInfo': {'id': 'CRO-2022-14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult patients', 'description': 'Adult cancer patients', 'interventionNames': ['Other: Pharmacogenetics, TDM and MedReview']}, {'label': 'Pediatric patients', 'description': 'Pediatric patients with chronic inflammatory diseases', 'interventionNames': ['Other: Pharmacogenetics, TDM and MedReview']}], 'interventions': [{'name': 'Pharmacogenetics, TDM and MedReview', 'type': 'OTHER', 'description': 'Patients will undergo pharmacogenetics, TDM and MedReview analyses according to the study protocol', 'armGroupLabels': ['Adult patients', 'Pediatric patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33081', 'city': 'Aviano', 'state': 'Pordenone', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Erika Cecchin, Ph.D., Head Pharmacologist', 'role': 'CONTACT', 'email': 'ececchin@cro.it', 'phone': '+39 0434 659667'}, {'name': 'Paolo Baldo, Head Hospital Pharmacist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marcella Montico, Statistician', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jerry Polesel, Statistician', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fabio Puglisi, M.D., Head Oncologist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sara Gagno, Ph.D., Pharmacist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bianca Posocco, Ph.D., Chemist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rossana Roncato, Ph.D., Pharmacologist', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centro di Riferimento Oncologico di Aviano (CRO)', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'zip': '34137', 'city': 'Trieste', 'state': 'Trieste', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Arbo, Head Pharmacist', 'role': 'CONTACT', 'email': 'anna.arbo@burlo.trieste.it'}], 'facility': 'IRCCS materno infantile Burlo Garofolo di Trieste', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}], 'centralContacts': [{'name': 'Paola Rossi', 'role': 'CONTACT', 'email': 'paola.rossi@regione.fvg.it', 'phone': '+39 040 3775581'}, {'name': 'Erika Cecchin', 'role': 'CONTACT', 'email': 'ececchin@cro.it', 'phone': '+39 0434 659 667'}], 'overallOfficials': [{'name': 'Erika Cecchin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro di Riferimento Oncologico di Aviano (CRO) - IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Direzione centrale salute, politiche sociali e disabilità', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centro di Riferimento Oncologico - Aviano', 'class': 'OTHER'}, {'name': 'IRCCS Burlo Garofolo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}