Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-01 @ 8:24 PM
Study NCT ID:
NCT00177268
Status:
RECRUITING
Last Update Posted:
2025-01-08
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D012751', 'term': 'Sezary Syndrome'}, {'id': 'D009182', 'term': 'Mycosis Fungoides'}, {'id': 'D004485', 'term': 'Eczema'}, {'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D059349', 'term': 'Urine Specimen Collection'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'White blood cells and/or skin biopsy tissue are retained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2032-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proteomics of Cutaneous T-cell lymphoma', 'timeFrame': 'Ongoing', 'description': 'Proteomic variables will be measured in blood and tissue of consented CTCL patients.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cutaneous T-cell Lymphoma', 'Sezary Syndrome', 'Mycosis Fungoides', 'Blood/tissue banking', 'eczema', 'atopic dermatitis'], 'conditions': ['Cutaneous T-cell Lymphoma', 'Sezary Syndrome', 'Mycosis Fungoides', 'Eczema', 'Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This is a tissue, urine, and blood banking protocol for cutaneous t-cell lymphoma (CTCL), eczema, and atopic dermatitis patients for current and future research.', 'detailedDescription': 'The purpose of this study is to provide a central mechanism for monitoring access to peripheral blood, urine, and skin specimens obtained from CTCL, eczema, and atopic dermatitis patients to monitor:\n\n* immunologic assays/flow cytometry\n* tumor progression/regression\n* genomic studies\n* proteomic studies\n* others germane to the advancement of CTCL treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with cutaneous t-cell lymphoma and/or Sezary syndrome and atopic dermatitis or eczema patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 or older\n* able and willing to provide informed consent\n* diagnosed with CTCL\n* diagnosed with either atopic dermatitis or eczema\n\nExclusion Criteria:\n\n* Lack of CTCL, atopic dermatitis, or eczema diagnosis in medical record'}, 'identificationModule': {'nctId': 'NCT00177268', 'briefTitle': 'Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Peripheral Blood, Urine and Skin Sample Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research', 'orgStudyIdInfo': {'id': 'STUDY19010322'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CTCL, atopic dermatitis, eczema', 'description': 'Those subjects with cutaneous t-cell lymphoma and Sezary syndrome, atopic dermatitis, or eczema may participate as appropriate with the potential for blood, tissue or urine sampling.', 'interventionNames': ['Other: Blood draw, skin biopsy or urine collection']}], 'interventions': [{'name': 'Blood draw, skin biopsy or urine collection', 'type': 'OTHER', 'description': 'Up to 9 blood draws/year of 60 ml of whole blood. One 6 mm punch biopsy may be obtained up to 4 times per year.', 'armGroupLabels': ['CTCL, atopic dermatitis, eczema']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Charity L Ruhl, LPN', 'role': 'CONTACT', 'email': 'ruhlcl@upmc.edu', 'phone': '4126472013'}, {'name': 'Oleg Akilov, MD, PhD', 'role': 'CONTACT', 'email': 'akilovoe@upmc.edu', 'phone': '412-647-4200'}, {'name': 'Louis Falo, M.D., Ph.D.', 'role': 'CONTACT'}, {'name': 'Patrizia Fuschiotti, PhD', 'role': 'CONTACT'}, {'name': 'Hassane Zarour, MD', 'role': 'CONTACT'}, {'name': 'Oleg E. Akilov, MD, Ph.D', 'role': 'CONTACT'}, {'name': 'Nicolena Verardi, PA-C', 'role': 'CONTACT'}], 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Charity L Ruhl, LPN', 'role': 'CONTACT', 'email': 'ruhlcl@upmc.edu', 'phone': '4126472013'}], 'overallOfficials': [{'name': 'Oleg E Akilov, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Dermatology', 'investigatorFullName': 'Oleg E. Akilov, MD, PhD', 'investigatorAffiliation': 'University of Pittsburgh'}}}}