Collecting Samples From Patients With Primary Systemic Amyloidosis
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|ClinicalTrials.gov Identifier: NCT00898235|
Recruitment Status : Recruiting
First Posted : May 12, 2009
Last Update Posted : February 19, 2018
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.
|Condition or disease||Intervention/treatment|
|Multiple Myeloma||Genetic: clonality analysis Genetic: polymerase chain reaction Genetic: protein analysis Other: biologic sample preservation procedure Other: laboratory biomarker analysis Procedure: fluorescence spectroscopy Procedure: quality-of-life assessment|
- 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 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 SF36 questionnaire.
|Study Type :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||Data, Tissue, Blood, and Urine Repository for Amyloid Diseases|
|Study Start Date :||January 2000|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||February 2037|
Genetic: clonality analysis
- Establish a repository to promote biochemical research [ Time Frame: life of study ]
- Collection of clinical material and information [ Time Frame: life of study ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898235
|Contact: Salli Fennesseyfirstname.lastname@example.org|
|United States, Massachusetts|
|Boston University Cancer Research Center||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Clinical Trials Office - Boston University Cancer Research Cen 617-638-8265|
|Principal Investigator:||Vaishali Sanchorawala, MD||Boston Medical Center|