NCT00898235

Collection of Samples and Clinical Data From Patients With Amyloid Diseases

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
GENETIC	clonality analysis	analyze clonality
GENETIC	polymerase chain reaction	analyze polymerase chain reaction
GENETIC	protein analysis	analyze protein
OTHER	biologic sample preservation procedure	preserve biologic samples
OTHER	laboratory biomarker analysis	analyze laboratory biomarkers
PROCEDURE	fluorescence spectroscopy	perform fluorescence spectroscopy on specimens
PROCEDURE	quality-of-life assessment	assess quality of life at each follow-up for life

Timeline

• Start date: 2000-01-01
• Primary completion: 2040-12-01
• Completion: 2040-12-01
• First posted: 2009-05-12
• Last updated: 2025-12-01

Locations

1 site across 1 country: United States