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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
Information provided by (Responsible Party):
Vaishali Sanchorawala, Boston Medical Center

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.

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

Detailed Description:


  • 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
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis
U.S. FDA Resources

Intervention Details:
    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

Primary Outcome Measures :
  1. Establish a repository to promote biochemical research [ Time Frame: life of study ]

Secondary Outcome Measures :
  1. Collection of clinical material and information [ Time Frame: life of study ]

Biospecimen Retention:   Samples With DNA
blood, urine, and tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants diagnosed, or with suspicion of having, primary systemic amyloidosis

Inclusion Criteria:


  • Diagnosis or suspicion of primary systemic amyloidosis


  • Referred to the Amyloid Treatment and Research Center at Boston University Medical Center


  • Not specified

Exclusion Criteria:

Information from the National Library of Medicine

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 Fennessey 617-638-8261 sally.fennessey@bmc.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      
Sponsors and Collaborators
Boston Medical Center
Principal Investigator: Vaishali Sanchorawala, MD Boston Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vaishali Sanchorawala, Principal Investigator, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00898235     History of Changes
Other Study ID Numbers: H-22838
CDR0000632869 ( Other Grant/Funding Number: Amyloid Resarch Fund at BUSM )
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vaishali Sanchorawala, Boston Medical Center:
primary systemic amyloidosis

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Proteostasis Deficiencies
Metabolic Diseases