Collection of Samples and Clinical Data From Patients With Amyloid Diseases
NCT ID: NCT00898235
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10000 participants
OBSERVATIONAL
2000-01-31
2040-12-31
Brief Summary
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PURPOSE: This research study is collecting samples from patients with amyloid diseases
Detailed Description
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* To establish and maintain a database of clinical material (i.e., blood, urine, and tissue) and information on patients with amyloid diseases.
OUTLINE: 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.
Quality of life is assessed by the 36-Item Short Form Survey (SF-36).
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Interventions
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clonality analysis
analyze clonality
polymerase chain reaction
analyze polymerase chain reaction
protein analysis
analyze protein
biologic sample preservation procedure
preserve biologic samples
laboratory biomarker analysis
analyze laboratory biomarkers
fluorescence spectroscopy
perform fluorescence spectroscopy on specimens
quality-of-life assessment
assess quality of life at each follow-up for life
Eligibility Criteria
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Inclusion Criteria
* Diagnosis or suspicion of amyloidosis
PATIENT CHARACTERISTICS:
* Referred to the Amyloid Treatment and Research Center at Boston University Medical Center
PRIOR CONCURRENT THERAPY:
* Not specified
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Boston Medical Center
OTHER
Responsible Party
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Principal Investigators
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Vaishali Sanchorawala, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center
Locations
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Boston University Cancer Research Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Office - Boston University Cancer Research Cen
Role: primary
References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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CDR0000632869
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H-22838
Identifier Type: -
Identifier Source: org_study_id