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Collection of Samples and Clinical Data From Patients With Amyloid Diseases

Data, Tissue, Blood, and Urine Repository for Amyloid Diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00898235
Enrollment
10000
Registered
2009-05-12
Start date
2000-01-31
Completion date
2040-12-31
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

primary systemic amyloidosis

Brief summary

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. PURPOSE: This research study is collecting samples from patients with amyloid diseases

Detailed description

OBJECTIVES: * 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).

Interventions

analyze clonality

GENETICpolymerase chain reaction

analyze polymerase chain reaction

GENETICprotein analysis

analyze protein

OTHERbiologic sample preservation procedure

preserve biologic samples

OTHERlaboratory biomarker analysis

analyze laboratory biomarkers

perform fluorescence spectroscopy on specimens

PROCEDUREquality-of-life assessment

assess quality of life at each follow-up for life

Sponsors

Boston Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * 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

None

Design outcomes

Primary

MeasureTime frame
Establish a repository to promote biochemical researchlife of study

Secondary

MeasureTime frame
Collection of clinical material and informationlife of study

Countries

United States

Contacts

Primary ContactVaishali Sanchorawala, MD
vaishali.sanchorawala@bmc.org617-638-8261
Backup ContactAnnie Jose, BS
annie.jose@bmc.org617 638 8213

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026