Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-02-17 @ 5:24 PM
Study NCT ID:
NCT04142567
Status:
COMPLETED
Last Update Posted:
2022-11-01
First Post:
2019-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of the Pharmacist in Detection of Drug Interactions Before Antitumor Treatment Initiation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 440}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2019-09-04', 'studyFirstSubmitQcDate': '2019-10-25', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Pharmacist intervention', 'timeFrame': 'up to 1 week from date of inclusion', 'description': 'Percentage of patients whom antitumora treatment or usual treatment has been changed by the pharmacist intervention'}], 'secondaryOutcomes': [{'measure': 'Detection of Drug -drug interactions', 'timeFrame': 'up to 1 week from date of inclusion', 'description': 'Number of drug drug interactions detected'}, {'measure': 'Clinical gradation of drug drug interactions', 'timeFrame': 'One year', 'description': 'Gradation by an independent experts comity of the clinical impact of prevented drug drug interaction'}, {'measure': 'Cost of the pharmacist intervention by avoided clinical consequence', 'timeFrame': 'One year', 'description': 'Cost evaluation of pharmacist for analysis and medication review with patient by avoided interaction'}, {'measure': 'Potential cost of the avoided clinical consequences', 'timeFrame': 'One year', 'description': 'Treatment cost of avoided clinical consequences , balanced with the probability of occurrence'}, {'measure': 'Adherence evaluation with oral cancer targeted therapy by therapeutic drug monitoring', 'timeFrame': 'day 15, 30 and 6 months after oral therapy initiation', 'description': 'Patients with plasma drug concentration below the 10th percentile will be classified as nonadherent patients'}, {'measure': 'Adherence evaluation with oral cancer targeted therapy by the 6 item-Girerd Scale', 'timeFrame': 'day 15, 30 and 6 months after oral therapy initiation', 'description': 'Patients with a Girerd score greater than or equal to 3 will be classified as nonadherent patients'}, {'measure': 'Adherence evaluation with oral cancer targeted therapy by pill count', 'timeFrame': '6 months after oral therapy initiation', 'description': 'Pill counts will be used to calculate the percent of total prescribed dose taken to prescribed during the 90-day period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug drug interactions', 'Pharmacist interventions', 'Cancer patients', 'Out patient setting'], 'conditions': ['Neoplasm']}, 'referencesModule': {'references': [{'pmid': '24041628', 'type': 'BACKGROUND', 'citation': 'Thomas-Schoemann A, Blanchet B, Bardin C, Noe G, Boudou-Rouquette P, Vidal M, Goldwasser F. Drug interactions with solid tumour-targeted therapies. Crit Rev Oncol Hematol. 2014 Jan;89(1):179-96. doi: 10.1016/j.critrevonc.2013.08.007. Epub 2013 Aug 28.'}, {'type': 'BACKGROUND', 'citation': 'P. Boudou Rouquette, A. Thomas-Schoemann, A. Chahwakilian et al., Clinical benefit of a one-day multidisciplinary work-up for risk assessment in unfit cancer patients. ESMO congress, abstract 1558; Amsterdam 2013'}, {'pmid': '28361167', 'type': 'BACKGROUND', 'citation': 'Bonnet C, Boudou-Rouquette P, Azoulay-Rutman E, Huillard O, Golmard JL, Carton E, Noe G, Vidal M, Orvoen G, Chah Wakilian A, Villeminey C, Blanchet B, Alexandre J, Goldwasser F, Thomas-Schoemann A. Potential drug-drug interactions with abiraterone in metastatic castration-resistant prostate cancer patients: a prevalence study in France. Cancer Chemother Pharmacol. 2017 May;79(5):1051-1055. doi: 10.1007/s00280-017-3291-z. Epub 2017 Mar 30.'}, {'pmid': '21741307', 'type': 'BACKGROUND', 'citation': 'Lees J, Chan A. Polypharmacy in elderly patients with cancer: clinical implications and management. Lancet Oncol. 2011 Dec;12(13):1249-57. doi: 10.1016/S1470-2045(11)70040-7. Epub 2011 Jul 6.'}, {'pmid': '17440160', 'type': 'BACKGROUND', 'citation': 'Riechelmann RP, Tannock IF, Wang L, Saad ED, Taback NA, Krzyzanowska MK. Potential drug interactions and duplicate prescriptions among cancer patients. J Natl Cancer Inst. 2007 Apr 18;99(8):592-600. doi: 10.1093/jnci/djk130.'}, {'pmid': '19147869', 'type': 'BACKGROUND', 'citation': 'Ruddy K, Mayer E, Partridge A. Patient adherence and persistence with oral anticancer treatment. CA Cancer J Clin. 2009 Jan-Feb;59(1):56-66. doi: 10.3322/caac.20004.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to evaluate the benefits of a pharmacist integration in an oncology ambulatory center, to prevent drug related problems (in particular drug drug interactions) at antitumor treatment initiation.\n\nThe hypothesis of this work is that a drug drug interaction will be observed in 30% of cancer patients and will have a major clinical impact in 1% of the cases. The primary endpoint is the prevalence of pharmacist interventions among patients who are going to receive an oral targeted therapy or cancer chemotherapy or immunotherapy', 'detailedDescription': 'The purpose of this observational study is to evaluate the benefits of a pharmacist integration in an oncology ambulatory center, to prevent drug related problems (in particular drug drug interactions) at antitumor treatment initiation.\n\nThe hypothesis of this work is that a drug drug interaction will be observed in 30% of cancer patients and will have a major clinical impact in 1% of the cases.\n\nThe primary endpoint is the prevalence of pharmacist interventions among cancer patients who are going to receive an oral targeted therapy (140 patients) or cancer chemotherapy or immunotherapy (300 patients).\n\nPharmacist interventions will be classified according to the SFPC (société française de pharmacie Clinique) classification.\n\nThe secondary endpoints are\n\n* The detection of drug drug interactions with theriaque software, Micromedex software and DDI predictor tool.\n* The clinical gradation by an independent expert comity of the clinical impact of avoided drug drug interaction. The expert comity will grade avoided clinical consequences in 3 levels (minor, moderate or major),\n* The Economic evaluation of pharmacist intervention: Cost of the project to evaluate drug drug interaction and benefits after evaluation of avoided clinical consequences\n* The Adherence evaluation of patients treated with oral cancer targeted therapy (Therefore, only patients under oral targeted therapy will be evaluated at Day0, Day15 ,Day 30 and Month 6 to determine adherence.)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer patients in outpatient setting, treated in two Paris hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* legal age patients\n* Affiliated to social security or with another insurance system\n* with a solid tumor\n* who are going to receive an antitumor treatment (chemotherapy, immunotherapy or oral targeted therapy)\n\nExclusion Criteria:\n\n* pregnant women\n* minor patient'}, 'identificationModule': {'nctId': 'NCT04142567', 'acronym': 'CHOPIN', 'briefTitle': 'Role of the Pharmacist in Detection of Drug Interactions Before Antitumor Treatment Initiation', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Role of the Clinical Pharmacist in an Oncology Ambulatory Center to Prevent Drug Related Problems Before Antitumor Treatment Initiation', 'orgStudyIdInfo': {'id': '2018-A03512-53'}}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'APHP -Cochin Hospital and Georges Pompidou European Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Audrey Thomas-Schoemann, PharmD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}