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Collection of Samples and Clinical Data From Patients With Amyloid Diseases

Sponsor
Boston Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT00898235
Collaborator
(none)
10,000
Enrollment
1
Location
445
Anticipated Duration (Months)
22.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • 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

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).

Study Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Data, Tissue, Blood, and Urine Repository for Amyloid Diseases
Actual Study Start Date :
Jan 1, 2000
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Feb 1, 2037

Outcome Measures

Primary Outcome Measures

  1. Establish a repository to promote biochemical research [life of study]

Secondary Outcome Measures

  1. Collection of clinical material and information [life of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
DISEASE CHARACTERISTICS:
  • Diagnosis or suspicion of amyloidosis
PATIENT CHARACTERISTICS:
  • Referred to the Amyloid Treatment and Research Center at Boston University Medical Center
PRIOR CONCURRENT THERAPY:
  • Not specified
Exclusion Criteria:

None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boston University Cancer Research Center Boston Massachusetts United States 02118

Sponsors and Collaborators

  • Boston Medical Center

Investigators

  • Principal Investigator: Vaishali Sanchorawala, MD, Boston Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00898235
Other Study ID Numbers:
  • H-22838
  • CDR0000632869
First Posted:
May 12, 2009
Last Update Posted:
Jan 27, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Boston Medical Center
primary systemic amyloidosis
Additional relevant MeSH terms:
Multiple Myeloma

Study Results

No Results Posted as of Jan 27, 2022