Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-25 @ 8:02 PM
Study NCT ID:
NCT00898235
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2009-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Collection of Samples and Clinical Data From Patients With Amyloid Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D000075363', 'term': 'Immunoglobulin Light-chain Amyloidosis'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D013050', 'term': 'Spectrometry, Fluorescence'}], 'ancestors': [{'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005470', 'term': 'Fluorometry'}, {'id': 'D008163', 'term': 'Luminescent Measurements'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood, urine, and tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2000-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2040-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2040-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establish a repository to promote biochemical research', 'timeFrame': 'life of study'}], 'secondaryOutcomes': [{'measure': 'Collection of clinical material and information', 'timeFrame': 'life of study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['primary systemic amyloidosis'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '40526008', 'type': 'DERIVED', 'citation': 'Ramireddy S, Prokaeva T, Chen H, Spencer B, Wong S, Dasari S, Dao L, McPhail ED, Sanchorawala V, Mendelson L. The Amyloidosis Intersection: Dual Amyloid Types in a Single Host. Eur J Haematol. 2025 Sep;115(3):287-298. doi: 10.1111/ejh.14429. Epub 2025 Jun 17.'}, {'pmid': '32130406', 'type': 'DERIVED', 'citation': 'Staron A, Burks EJ, Lee JC, Sarosiek S, Sloan JM, Sanchorawala V. Assessment of minimal residual disease using multiparametric flow cytometry in patients with AL amyloidosis. Blood Adv. 2020 Mar 10;4(5):880-884. doi: 10.1182/bloodadvances.2019001331.'}, {'pmid': '31306033', 'type': 'DERIVED', 'citation': 'Staron A, Connors LH, Ruberg FL, Mendelson LM, Sanchorawala V. A new era of amyloidosis: the trends at a major US referral centre. Amyloid. 2019 Dec;26(4):192-196. doi: 10.1080/13506129.2019.1640672. Epub 2019 Jul 15.'}, {'pmid': '30333122', 'type': 'DERIVED', 'citation': 'Lilleness B, Ruberg FL, Mussinelli R, Doros G, Sanchorawala V. Development and validation of a survival staging system incorporating BNP in patients with light chain amyloidosis. Blood. 2019 Jan 17;133(3):215-223. doi: 10.1182/blood-2018-06-858951. Epub 2018 Oct 17.'}, {'pmid': '27460276', 'type': 'DERIVED', 'citation': 'Shu J, Lo S, Phillips M, Sun F, Seldin DC, Berenbaum I, Berk JL, Sanchorawala V. Depression and anxiety in patients with AL amyloidosis as assessed by the SF-36 questionnaire: experience in 1226 patients. Amyloid. 2016 Sep;23(3):188-193. doi: 10.1080/13506129.2016.1208081. Epub 2016 Jul 27.'}, {'pmid': '22733017', 'type': 'DERIVED', 'citation': "Cowan AJ, Skinner M, Seldin DC, Berk JL, Lichtenstein DR, O'Hara CJ, Doros G, Sanchorawala V. Amyloidosis of the gastrointestinal tract: a 13-year, single-center, referral experience. Haematologica. 2013 Jan;98(1):141-6. doi: 10.3324/haematol.2012.068155. Epub 2012 Jun 24."}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Collecting and storing samples of blood, urine, tissue and data from patients with amyloid diseases to test in the laboratory may help the study of this disease in the future.\n\nPURPOSE: This research study is collecting samples from patients with amyloid diseases', 'detailedDescription': 'OBJECTIVES:\n\n* To establish and maintain a database of clinical material (i.e., blood, urine, and tissue) and information on patients with amyloid diseases.\n\nOUTLINE: Blood, urine, tissue, and bone marrow samples are collected during standard laboratory evaluations to maintain a repository of biospecimens in the Gerry Amyloid Research Laboratory, to permit the correlation of clinical results with measured biological events, and for future research studies. Bone marrow RNA samples are examined for immunoglobulin light-chain gene sequences and amino acids by polymerase chain reaction and positional cloning. Blood serum and urine samples are evaluated for amyloid protein stability by high-resolution calorimetry, isothermal-titration calorimetry, and far- and near-UV circular dichroism and fluorescence spectroscopy. Urine samples are also examined for post-translational modifications (e.g., glycosylation, sulfation, and cross-linking) to identify common features unique to amyloid proteins. Tissue samples are analyzed for biochemical and biophysical properties and for post-translational modifications in light chains.\n\nQuality of life is assessed by the 36-Item Short Form Survey (SF-36).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants diagnosed, or with suspicion of having, amyloidosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDISEASE CHARACTERISTICS:\n\n* Diagnosis or suspicion of amyloidosis\n\nPATIENT CHARACTERISTICS:\n\n* Referred to the Amyloid Treatment and Research Center at Boston University Medical Center\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT00898235', 'briefTitle': 'Collection of Samples and Clinical Data From Patients With Amyloid Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Data, Tissue, Blood, and Urine Repository for Amyloid Diseases', 'orgStudyIdInfo': {'id': 'H-22838'}, 'secondaryIdInfos': [{'id': 'CDR0000632869', 'type': 'OTHER_GRANT', 'domain': 'Amyloid Resarch Fund at BUSM'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'clonality analysis', 'type': 'GENETIC', 'description': 'analyze clonality'}, {'name': 'polymerase chain reaction', 'type': 'GENETIC', 'description': 'analyze polymerase chain reaction'}, {'name': 'protein analysis', 'type': 'GENETIC', 'description': 'analyze protein'}, {'name': 'biologic sample preservation procedure', 'type': 'OTHER', 'description': 'preserve biologic samples'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'analyze laboratory biomarkers'}, {'name': 'fluorescence spectroscopy', 'type': 'PROCEDURE', 'description': 'perform fluorescence spectroscopy on specimens'}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE', 'description': 'assess quality of life at each follow-up for life'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Office - Boston University Cancer Research Cen', 'role': 'CONTACT', 'phone': '617-638-8265'}], 'facility': 'Boston University Cancer Research Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Vaishali Sanchorawala, MD', 'role': 'CONTACT', 'email': 'vaishali.sanchorawala@bmc.org', 'phone': '617-638-8261'}, {'name': 'Annie Jose, BS', 'role': 'CONTACT', 'email': 'annie.jose@bmc.org', 'phone': '617 638 8213'}], 'overallOfficials': [{'name': 'Vaishali Sanchorawala, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}