Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT02989792
Status:
COMPLETED
Last Update Posted:
2019-05-08
First Post:
2016-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Genetic Variation of Dopamine Pathway in Patients With Chronic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D005838', 'term': 'Genotype'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-06', 'studyFirstSubmitDate': '2016-12-05', 'studyFirstSubmitQcDate': '2016-12-08', 'lastUpdatePostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Single Nucleotide Polymorphisms (SNPs) variation of catechol-O-methyltransferase', 'timeFrame': 'Time zero equals baseline', 'description': 'SNPs will be analyzed with Sanger based genotyping or equivalent method'}, {'measure': 'Number of participants with SNPs variation of monoamine oxidase', 'timeFrame': 'Time zero equals baseline', 'description': 'SNPs will be analyzed with Sanger based genotyping or equivalent method'}, {'measure': 'Number of participants with SNPs variation of dopamine B hydroxylase', 'timeFrame': 'Time zero equals baseline', 'description': 'SNPs will be analyzed with Sanger based genotyping or equivalent method'}, {'measure': 'Number of participants with SNPs variation of dopamine receptor 3', 'timeFrame': 'Time zero equals baseline', 'description': 'SNPs will be analyzed with Sanger based genotyping or equivalent method'}, {'measure': 'Number of participants with SNPs variation of brain-derived neurotropic factor genes', 'timeFrame': 'Time zero equals baseline', 'description': 'SNPs will be analyzed with Sanger based genotyping or equivalent method'}], 'secondaryOutcomes': [{'measure': 'Number of participants with SNPs variation of tryptophan hydroxylase-2', 'timeFrame': 'Time zero equals baseline', 'description': 'SNPs will be analyzed with Sanger based genotyping or equivalent method'}, {'measure': 'Number of participants with SNPs variation of 5-hydroxytryptamine transporter', 'timeFrame': 'Time zero equals baseline', 'description': 'SNPs will be analyzed with Sanger based genotyping or equivalent method'}, {'measure': 'Number of participants with SNPs variation of 5-hydroxytryptamine receptor 2A', 'timeFrame': 'Time zero equals baseline', 'description': 'SNPs will be analyzed with Sanger based genotyping or equivalent method'}, {'measure': 'Number of participants with SNPs variation of serotonin transporter gene-linked polymorphic region genes', 'timeFrame': 'Time zero equals baseline', 'description': 'SNPs will be analyzed with Sanger based genotyping or equivalent method'}, {'measure': 'Number of participants with SNPs variation of opioid receptor gene', 'timeFrame': 'Time zero equals baseline', 'description': 'SNPs will be analyzed with Sanger based genotyping or equivalent method'}, {'measure': 'Number of participants with SNPs variation of fatty acid amid hydrolase gene', 'timeFrame': 'Time zero equals baseline', 'description': 'SNPs will be analyzed with Sanger based genotyping or equivalent method'}, {'measure': 'Assessment of Cronbach alpha of the personality questionnaire used in this study and the former ones', 'timeFrame': 'Time zero equals baseline', 'description': "Cronbach's alpha between 0 and 1"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain'], 'conditions': ['Peripheral Neuropathy', 'Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Patients having completed former trials T1001-01 or T1001-02 will undergo one blood sampling for genotyping purposes. In addition they will compete the personality questionnaires they had completed in the former trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have completed T1001-01 or T1001-02 study (Visit 5 completed)\n* are men or women of at least 18 years of age\n* have given written informed consent approved by the relevant Ethics Committee governing the study sites\n\nExclusion Criteria:\n\n* have any close relationship with the Investigators or the Sponsor\n* are under legal protection, according to the national law'}, 'identificationModule': {'nctId': 'NCT02989792', 'briefTitle': 'A Study to Investigate the Genetic Variation of Dopamine Pathway in Patients With Chronic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Tools4Patient'}, 'officialTitle': 'A Study to Investigate the Genetic Variation of Dopamine Pathway Associated With the Observed Effects of a New Treatment in Former Studies in Patients With Chronic Pain', 'orgStudyIdInfo': {'id': 'T1001-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Unique study arm', 'interventionNames': ['Genetic: Blood sampling for genotyping', 'Other: Personality Questionnaires completion']}], 'interventions': [{'name': 'Blood sampling for genotyping', 'type': 'GENETIC', 'description': 'Venous punction of maximum 10 millilitres', 'armGroupLabels': ['Unique study arm']}, {'name': 'Personality Questionnaires completion', 'type': 'OTHER', 'description': 'Completion of the following questionnaires: Multidimensional Personality Questionnaire (MPSQ), Interpersonal Reactivity Index (IRI) and Behavioral inhibition system/ Behavioral activation systems (BISBAS) questionnaires', 'armGroupLabels': ['Unique study arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'ATC SA', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CIC Clermont-Ferrand CHU G. Montpied', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '38610', 'city': 'Gières', 'country': 'France', 'facility': 'Eurofins Optimed', 'geoPoint': {'lat': 45.17997, 'lon': 5.78935}}, {'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Alvaro Pereira', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tools4Patient'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tools4Patient', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}