Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
Study NCT ID:
NCT03977766
Status:
UNKNOWN
Last Update Posted:
2019-06-06
First Post:
2019-06-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of a Process of Digital Validation of Chemotherapies in a Day Treatment Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2021-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-05', 'studyFirstSubmitDate': '2019-06-04', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of the digital application', 'timeFrame': '6 weeks', 'description': 'Number of prevalidation of the chemotherapy by the digital application compared to the number of corresponding validation of the chemotherapy by the physician'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['digital application', 'outpatients chemotherapy', 'chemotherapy validation'], 'conditions': ['Solid Tumor, Adult']}, 'descriptionModule': {'briefSummary': "The aim of CPV 2.0 study is to evaluate a process of digital prevalidation of outpatients chemotherapy thanks to a numeric application. This digital tool is based on the combination of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to a decisional algorithm.\n\nAfter cycle 1, chemotherapy digital prevalidation will be done with the help of a nurse for two consecutive cycles (cycles 2 and 3). Patients will then have to use to application by themselves for the two following cycles (cycles 4 and 5)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\<80 (if age\\>70 years, a G8 score\\>14 is required)\n* ECOG\\<3\n* Pathology (solid tumor, in neoadjuvant, adjuvant or metastatic setting)\n* Patient receiving an IV cytotoxic chemotherapy in a day treatlent unit for at least 5 cycles, with at least an injection at day 1, day 8 and day 15\n* Familiar with digital tools\n\nExclusion Criteria:\n\n* Emergency\n* patient feeling unease with the use of a smartphone'}, 'identificationModule': {'nctId': 'NCT03977766', 'acronym': 'CPV2-0', 'briefTitle': 'Feasibility of a Process of Digital Validation of Chemotherapies in a Day Treatment Unit', 'organization': {'class': 'OTHER', 'fullName': 'Institut Paoli-Calmettes'}, 'officialTitle': 'Feasibility of a Process of Digital Validation of Outpatients Chemotherapies in a Day Treatment Unit', 'orgStudyIdInfo': {'id': 'CPV 2.0-IPC 2018-054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nurse then patient digital prevalidation of chemotherapy', 'description': 'Outpatient Chemotherapy prevalidation will done\n\n* with the help of a nurse, using the digital application, for cycle 2 and 3.\n* by the patient alone, using the digital application, for cycle 4 and 5.', 'interventionNames': ['Procedure: Chemotherapy prevalidation']}], 'interventions': [{'name': 'Chemotherapy prevalidation', 'type': 'PROCEDURE', 'description': 'Outpatient Chemotherapy prevalidation will done\n\n* with the help of a nurse, using the digital application, for cycle 2 and 3.\n* by the patient alone, using the digital application, for cycle 4 and 5.', 'armGroupLabels': ['nurse then patient digital prevalidation of chemotherapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dominique Genre, MD', 'role': 'CONTACT', 'email': 'drci.up@ipc.unicancer.fr', 'phone': '+33491223778'}], 'overallOfficials': [{'name': 'Loui Tassy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Paoli-Calmettes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}