Collecting Samples From Patients With Primary Systemic Amyloidosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boston Medical Center
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00898235
First received: May 9, 2009
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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 Intervention
Multiple Myeloma and Plasma Cell Neoplasm
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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Data, Tissue, Blood, and Urine Repository for Amyloid Diseases

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Collection of clinical material and information [ Time Frame: life of study ] [ Designated as safety issue: No ]
  • Establish a repository to promote biochemical research [ Time Frame: life of study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood, urine, and tissue


Estimated Enrollment: 10000
Study Start Date: January 2000
Estimated Study Completion Date: February 2037
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
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
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Participants diagnosed, or with suspicion of having, primary systemic amyloidosis

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis or suspicion of primary systemic amyloidosis

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898235

Locations
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
Investigators
Principal Investigator: David C. Seldin, MD, PhD Boston Medical Center
  More Information

Additional Information:
No publications provided by Boston Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00898235     History of Changes
Other Study ID Numbers: CDR0000632869, BUMC-H-22838
Study First Received: May 9, 2009
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Medical Center:
primary systemic amyloidosis

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

ClinicalTrials.gov processed this record on September 18, 2014