Clinical Trial: Collecting Samples From Patients With Primary Systemic Amyloidosis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Data, Tissue, Blood, and Urine Repository for Amyloid Diseases
Brief Summary:
RATIONALE: Collecting and storing samples of blood, urine, and tissue from patients with primary systemic amyloidosis 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 primary systemic amyloidosis.
Detailed Summary:
OBJECTIVES:
- To establish and maintain a database of clinical material (i.e., blood, urine, and tissue) and information on patients with primary systemic amyloidosis.
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 PCR 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 SF36 questionnaire.
Sponsor: Boston Medical Center
Current Primary Outcome: Establish a repository to promote biochemical research [ Time Frame: life of study ]
Original Primary Outcome:
- Collection of clinical material and information
- Establish a repository to promote biochemical research
Current Secondary Outcome: Collection of clinical material and information [ Time Frame: life of study ]
Original Secondary Outcome:
Information By: Boston Medical Center
Dates:
Date Received: May 9, 2009
Date Started: January 2000
Date Completion: February 2037
Last Updated: July 19, 2016
Last Verified: July 2016
