Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-01-09 @ 5:20 AM
Study NCT ID:
NCT02871050
Status:
WITHDRAWN
Last Update Posted:
2018-07-31
First Post:
2016-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Castleman Disease Collaborative Network Biobank
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005871', 'term': 'Castleman Disease'}, {'id': 'D006965', 'term': 'Hyperplasia'}, {'id': 'C537834', 'term': 'Macular dystrophy, corneal type 1'}, {'id': 'C537372', 'term': "Multi-centric Castleman's Disease"}], 'ancestors': [{'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Lymph node and/or bone marrow slides and/or tissue blocks, saliva, whole blood, and serum will be collected both prospectively and retrospectively.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'An alternative Biobank Project was initiated.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-28', 'studyFirstSubmitDate': '2016-08-15', 'studyFirstSubmitQcDate': '2016-08-17', 'lastUpdatePostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Samples Collected', 'timeFrame': '3 years', 'description': 'Number of samples collected across different subgroups (e.g. blood products, lymph node)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Biobank', 'biorepository', 'Castlebank', 'Castleman Disease', 'CD', 'MCD', 'iMCD', 'Castleman', "Castleman's Disease", "multicentric Castleman's disease", 'multicentric Castleman disease', 'Angiofollicular Lymph Hyperplasia'], 'conditions': ['Castleman Disease', "Castleman's Disease", 'Giant Lymph Node Hyperplasia', 'Angiofollicular Lymph Hyperplasia', 'Angiofollicular Lymph Node Hyperplasia', 'Angiofollicular Lymphoid Hyperplasia', 'GLNH', 'Hyperplasia', 'Giant Lymph Node']}, 'referencesModule': {'references': [{'pmid': '27063975', 'type': 'BACKGROUND', 'citation': "Liu AY, Nabel CS, Finkelman BS, Ruth JR, Kurzrock R, van Rhee F, Krymskaya VP, Kelleher D, Rubenstein AH, Fajgenbaum DC. Idiopathic multicentric Castleman's disease: a systematic literature review. Lancet Haematol. 2016 Apr;3(4):e163-75. doi: 10.1016/S2352-3026(16)00006-5. Epub 2016 Mar 17."}, {'pmid': '24622327', 'type': 'BACKGROUND', 'citation': 'Fajgenbaum DC, van Rhee F, Nabel CS. HHV-8-negative, idiopathic multicentric Castleman disease: novel insights into biology, pathogenesis, and therapy. Blood. 2014 May 8;123(19):2924-33. doi: 10.1182/blood-2013-12-545087. Epub 2014 Mar 12.'}], 'seeAlsoLinks': [{'url': 'http://www.cdcn.org', 'label': 'website includes information on Castleman Disease'}, {'url': 'http://www.cdcn.org/samples', 'label': 'Please visit this link to sign-up and contribute samples!'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to create a biobank, which collects, stores, and distributes samples of human tissues, blood, and related health information to qualified scientists, in order to help doctors and researchers better understand why Castleman Disease occurs and develop ways to better treat and prevent it.', 'detailedDescription': 'The CDCN proposes to establish a biobank and associated clinical data for Castleman disease. Tissue and fluid (blood and saliva) samples will be collected both prospectively and retrospectively. Blood or saliva samples may also be collected from relatives of Castleman patients. Because of the scarcity of these samples, it will be necessary to make efforts to access all available cases. Many cases will occur at hospitals that do not have an existing relationship with the CDCN and may not have experience with tissue procurement; however, this is the only way to obtain the vast majority of samples. Samples may be used immediately, banked for future use, or further processed into DNA, cell lines, tissue microarrays, etc.\n\nThe samples will be stored at Precision for Medicine, a biorepository company that specializes in collection, processing, storage and distribution of biospecimens. Only researchers (US or international) who have applied to the CDCN and have been approved by the Biobank Advisory Board will be eligible to access biospecimens and/or data. The Biobank Advisory Board will be comprised of clinicians and scientists with experience in clinical and investigational practices in Castleman Disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Castleman Disease patients worldwide', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Potential study participants may be of any age, gender, or ethnicity who have been diagnosed with Castleman disease\n\nExclusion Criteria\n\n* None'}, 'identificationModule': {'nctId': 'NCT02871050', 'acronym': '"Castlebank"', 'briefTitle': 'Castleman Disease Collaborative Network Biobank', 'organization': {'class': 'OTHER', 'fullName': 'Castleman Disease Collaborative Network'}, 'officialTitle': 'The Castleman Disease Collaborative Network Biobank: A Collection of Biospecimens and Clinical Data to Facilitate Research', 'orgStudyIdInfo': {'id': '#31132/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Castleman Disease Patients', 'description': 'Potential study participants may be of any age, gender, or ethnicity who have been diagnosed with Castleman disease.', 'interventionNames': ['Other: Sample Collection']}], 'interventions': [{'name': 'Sample Collection', 'type': 'OTHER', 'description': 'Excess blood sample tubes and/or buccal swabs or saliva will have DNA and RNA extracted and serum and plasma separated out to be stored for future research purposes based on the results of this preliminary research.', 'armGroupLabels': ['Castleman Disease Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19146', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Castleman Disease Collaborative Network', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'David C Fajgenbaum, MD, MBA, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Executive Director of Castleman Disease Collaborative Network'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Qualified Researchers, who apply for access to the database and are subsequently approved, will be given access to a limited dataset with direct identifiers removed in an Excel compatible file format or single SAS data files. The Biobank Advisory Board will review applications from qualified researchers on an ongoing basis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Castleman Disease Collaborative Network', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}