Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-30 @ 3:21 PM
Study NCT ID:
NCT00956033
Status:
COMPLETED
Last Update Posted:
2014-12-24
First Post:
2009-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skin Biopsies in Chemotherapy-Induced Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'skin biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-23', 'studyFirstSubmitDate': '2009-08-10', 'studyFirstSubmitQcDate': '2009-08-10', 'lastUpdatePostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraepidermal nerve fiber density/pain intensity', 'timeFrame': 'one timepoint, i.e. date of skin biopsy', 'description': 'correlation between intraepidermal nerve fiber density and pain intensity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer', 'Peripheral Neuropathy', 'Bortezomib'], 'conditions': ['Multiple Myeloma', 'Peripheral Neuropathy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.erasmusmc.nl/neurologie', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Neuropathy is a common side effect of chemotherapeutics used for the treatment of multiple myeloma, including vincristine, thalidomide and bortezomib. The neuropathy induced by these drugs is often preferentially small fiber. Small fiber neuropathies are difficult to diagnose and quantify using conventional electromyography. Determining intra-epidermal nerve fiber density (IENFD) in skin biopsies from diabetes and AIDS patients has been shown to be a more sensitive and more specific ancillary investigation to establish the diagnosis of small fiber neuropathy. In this study the investigators aim to establish the sensitivity of IENFD measurements in skin biopsies from patients with multiple myeloma treated with bortezomib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with multiple myeloma receiving bortezomib in a large university hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with multiple myeloma receiving bortezomib\n\nExclusion Criteria:\n\n* Patients not able to provide informed consent\n* Patients with coagulation disturbances or immunocompromised patients'}, 'identificationModule': {'nctId': 'NCT00956033', 'briefTitle': 'Skin Biopsies in Chemotherapy-Induced Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Skin Biopsies in Chemotherapy-induced Neuropathy', 'orgStudyIdInfo': {'id': 'MEC2008-305'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with multiple myeloma'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000CA', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Erasmus MC, Centrumlocatie en Daniel den Hoed', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Joost L Jongen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'J.L.M. Jongen, MD, PhD', 'investigatorFullName': 'Joost LM Jongen', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}