Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-02-25 @ 9:40 PM
Study NCT ID:
NCT02893059
Status:
WITHDRAWN
Last Update Posted:
2021-06-18
First Post:
2016-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Data Collection Tool in Clinical Research: Comparison Between the Data Collected by Patient Diary and Data From Medical Administrative Databases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'the investigator has left the facility', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-14', 'studyFirstSubmitDate': '2016-09-02', 'studyFirstSubmitQcDate': '2016-09-07', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison of data collected in a patient diary and data stored in the database of health insurance', 'timeFrame': '6 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Case Report Form', 'Declaration Bias', 'Health Insurance Database']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to estimate the reporting bias of patients in terms of prescripted drug and care consumption by comparing data collected in a patient diary and database of health insurance .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of incident and prevalent cases of patients with chronic disease (diabetes, rheumatoid arthritis, chronic renal failure) or incident cases of prostate cancer, breast cance or colorectal cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* incident and prevalent cases of patients with type I or type II diabetes. arthritis:\n* incident and prevalent cases of rheumatoid arthritis patients defined according to the ACR-EULAR criteria 2010 (Aletaha D et al, 2010).\n\nRenal failure :\n\n• incident and prevalent cases of patients with kidney disease stage 3 or 4, transplanted or not.\n\nProstate cancer :\n\n• Incident cases of patients with prostate cancer regardless of the stage at diagnosis (positive prostate biopsy).\n\nBreast cancer :\n\n• Incident cases of patients with breast cancer regardless of the stage at diagnosis (biopsy positive breast).\n\nColorectal cancer :\n\n• Incident cases of patients with colorectal cancer regardless of the stage at diagnosis (colonoscopy and polyp biopsy positive).\n\nExclusion Criteria:\n\n\\- The subject participates in an experimental study of research affecting the therapeutic management of the patient.\n\n* The subject is exclusion period determined by a previous study.\n* The subject is under judicial protection, guardianship or curatorship.\n* It is not possible to give informed about information\n* The subject does not read French and is not autonomous filling a questionnaire.\n* The patient has psychiatric disorders.\n* The subject is an emergency.\n* Monitoring between patient visits than 6 months.'}, 'identificationModule': {'nctId': 'NCT02893059', 'acronym': 'CORD', 'briefTitle': 'Evaluation of a Data Collection Tool in Clinical Research: Comparison Between the Data Collected by Patient Diary and Data From Medical Administrative Databases', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Evaluation of a Data Collection Tool in Clinical Research: Comparison Between the Data Collected by Patient Diary and Data From Medical Administrative Databases', 'orgStudyIdInfo': {'id': 'PHRC/2014/CC-01'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'christel castelli, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU Nimes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}