Collection of Samples and Clinical Data From Patients With Amyloid Diseases

Multiple Myeloma Clinical Trial

Official title:

Data, Tissue, Blood, and Urine Repository for Amyloid Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00898235
• Other study ID #: H-22838
• Secondary ID: CDR0000632869
• Status: Recruiting
• Start date: January 2000
• Est. completion date: December 2040

Study information

• Verified date: January 2024
• Source: Boston Medical Center
• Contact: Vaishali Sanchorawala, MD
• Phone: 617-638-8261
• Email: vaishali.sanchorawala[@]bmc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2040
• Est. primary completion date: December 2040
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma

Intervention

Genetic:
• clonality analysis
analyze clonality
• polymerase chain reaction
analyze polymerase chain reaction
• protein analysis
analyze protein

Other:
• biologic sample preservation procedure
preserve biologic samples
• laboratory biomarker analysis
analyze laboratory biomarkers

Procedure:
• fluorescence spectroscopy
perform fluorescence spectroscopy on specimens
• quality-of-life assessment
assess quality of life at each follow-up for life

Locations

Country	Name	City	State
United States	Boston University Cancer Research Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish a repository to promote biochemical research		life of study
Secondary	Collection of clinical material and information		life of study