Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-30 @ 9:21 PM
Study NCT ID:
NCT02666456
Status:
UNKNOWN
Last Update Posted:
2016-01-28
First Post:
2016-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Sensory Phenotype on the Risk of Developing Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D059348', 'term': 'Peripheral Nerve Injuries'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'lastUpdateSubmitDate': '2016-01-25', 'studyFirstSubmitDate': '2016-01-11', 'studyFirstSubmitQcDate': '2016-01-25', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Somatosensory phenotype detected by quantitative sensory testing (QST)', 'timeFrame': 'Single assessment at baseline (cross-sectional study). Report of complete cohort data at study completion', 'description': 'The somatosensory phenotype will be assessed by quantitative sensory testing (QST) once at baseline'}, {'measure': 'Change of neuropathic pain: Development and chronification of neuropathic pain detected by DN4 questionnaire', 'timeFrame': 'Assessment of change of neuropathic pain from baseline and 6 months after study enrollment (longitudinal study). Report of complete cohort data at study completion.', 'description': 'Assessment with DN4 pain questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neuropathic Pain', 'Polyneuropathy', 'Peripheral Nerve Injury']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cordis.europa.eu/project/rcn/193238_en.html', 'label': 'Funding source'}, {'url': 'http://www.ndcn.ox.ac.uk/research/neural-injury-group/research-projects/dolorisk', 'label': 'WEbsite'}]}, 'descriptionModule': {'briefSummary': 'Cross-sectional and longitudinal analysis of the somatosensory phenotype, assessed by quantitative sensory testing (QST) and Information obtained by questionnaires to detect risk factors for neuropathic pain development and chronification in painless and chronic pain patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Painless patients and patients with chronic peripheral neuropathic pain.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic peripheral neuropathic pain or\n* Painless Patient with risk to develop neuropathic pain (post-surgery, chemotherapy-induced)\n\nExclusion Criteria:\n\n* Minors'}, 'identificationModule': {'nctId': 'NCT02666456', 'briefTitle': 'The Influence of Sensory Phenotype on the Risk of Developing Neuropathic Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Kiel'}, 'officialTitle': 'DOLORisk: Understanding Risk Factors and Determinants for Neuropathic Pain - The Influence of Sensory Phenotype on the Risk of Developing Neuropathic Pain', 'orgStudyIdInfo': {'id': 'DOLORisk WP4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cross-sectional cohort', 'description': 'Patients with chronic peripheral neuropathic pain', 'interventionNames': ['Other: QST, Questionnaires']}, {'label': 'Longitudinal cohort', 'description': 'Painless patients before and after potential chronic neuropathic pain-inducing interventions (chemotherapy, Operation)', 'interventionNames': ['Other: QST, Questionnaires']}], 'interventions': [{'name': 'QST, Questionnaires', 'type': 'OTHER', 'description': 'Assessment of sensory phenotype by QST and questionnaires', 'armGroupLabels': ['Cross-sectional cohort', 'Longitudinal cohort']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andreas Binder, MD', 'role': 'CONTACT', 'email': 'andreas.binder@uksh.de', 'phone': '+49 431 597', 'phoneExt': '8822'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kiel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med.', 'investigatorFullName': 'Andras Binder', 'investigatorAffiliation': 'University of Kiel'}}}}