Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-01-04 @ 5:02 PM
Study NCT ID:
NCT03098303
Status:
COMPLETED
Last Update Posted:
2020-08-26
First Post:
2017-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Criteria Associated With Patient Willingness to Participate in Biomedical Research
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2016-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-24', 'studyFirstSubmitDate': '2017-03-27', 'studyFirstSubmitQcDate': '2017-03-27', 'lastUpdatePostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptation or refusal to participate in a biomedical research study', 'timeFrame': 'Day 0 (cross-sectional study)', 'description': 'Positive or negative response to the question "If a biomedical research protocole were proposed to you, would you accept to participate?"'}], 'secondaryOutcomes': [{'measure': 'The PROTOACCEPT questionnaire', 'timeFrame': 'Day 0 (cross-sectional study)', 'description': 'The PROTOACCEPT questionnaire (see links below).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Consulting in Pneumology Department, But Not for Oncology or Tobacology']}, 'referencesModule': {'references': [{'pmid': '32791969', 'type': 'RESULT', 'citation': 'Pahus L, Suehs CM, Halimi L, Bourdin A, Chanez P, Jaffuel D, Marciano J, Gamez AS, Vachier I, Molinari N. Patient distrust in pharmaceutical companies: an explanation for women under-representation in respiratory clinical trials? BMC Med Ethics. 2020 Aug 13;21(1):72. doi: 10.1186/s12910-020-00509-y.'}, {'pmid': '30922104', 'type': 'RESULT', 'citation': 'Molinari N, Suehs C, Vachier I, Pahus L, Halimi L, Gamez AS, Chanez P, Bourdin A. Adverse publicity of serious side effects to healthy volunteers has limited effect on willingness-to-participate in clinical trials. Clin Trials. 2019 Aug;16(4):440-442. doi: 10.1177/1740774519840268. Epub 2019 Mar 29. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://osf.io/gccjd/', 'label': 'The PROTOACCEPT patient questionnaire'}, {'url': 'https://osf.io/nsjjr/', 'label': 'PROTOACCEPT on the Open Science Framework'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in a clinical research protocol when seen in during a pneumology consultation (excluding oncology and tobaccology).', 'detailedDescription': 'The secondary objectives of this study are:\n\n* To compare patient acceptance rates for participation in a clinical research protocol before and after January 15, 2016.\n* To determine the variables associated with accepting or refusing to participate in a clinical research protocol for patients seen during a pneumology consultation (excluding oncology and tobaccology) before January 15, 2016.\n* To determine the variables associated with accepting or refusing to participate in a clinical research protocol for patients seen during a pneumology consultation (excluding oncology and tobaccology) after January 15, 2016.\n* To describe the patient population seen during pneumology consultations.\n* To determine the variables associated with accepting or refusing to participate in a clinical research protocol sponsored by a pharmaceutical laboratory.\n* To determine the variables associated with accepting or refusing to participate in a clinical research protocol sponsored by an academic institution.\n* Construct clusters (homogeneous groups) of patients seen during the pneumology consultations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The target population corresponds to patients with respiratory disease. This study will be proposed to all patients consulting (excluding oncology and tobacco) in the associated departments.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient was informed about the study.\n* The patient is scheduled for a consult in the pneumology department\n\nExclusion Criteria:\n\n* The patient is under judicial protection or is an adult under any kind of guardianship\n* The patient expresses opposition to the study\n* It is impossible to correctly inform the patient about the study\n* The patient cannot fluently read French\n* The patient is pregnant\n* The patient is breastfeeding\n* The patient has cancer\n* The patient is consulting in tabaccology'}, 'identificationModule': {'nctId': 'NCT03098303', 'acronym': 'PROTOACCEPT', 'briefTitle': 'Criteria Associated With Patient Willingness to Participate in Biomedical Research', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Criteria Associated With Patient Willingness to Participate in Biomedical Research: a Prospective, Observational Study', 'orgStudyIdInfo': {'id': '9373'}, 'secondaryIdInfos': [{'id': '2014-A01201-46', 'type': 'OTHER', 'domain': 'RCB number'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34760', 'city': 'Boujan-sur-Libron', 'country': 'France', 'facility': 'Polyclinique Saint-Privat', 'geoPoint': {'lat': 43.37082, 'lon': 3.24749}}, {'zip': '13700', 'city': 'Marignane', 'country': 'France', 'facility': 'Clinique de Marignane', 'geoPoint': {'lat': 43.41727, 'lon': 5.21462}}, {'zip': '13915', 'city': 'Marseille', 'country': 'France', 'facility': 'APHM - Hôpital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Arnaud Bourdin, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Montpellier University Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}