Clinical Trial
Study Details
Status
RECRUITING
Study ID #
NCT00898235
Study Start
Primary Completion
Study Completion
Enrollment
10000
Study Type
Observational
Interventions
quality-of-life assessment

assess quality of life at each follow-up for life

Primary Outcomes
Measure
Establish a repository to promote biochemical research
Timeframe
life of study
Secondary Outcomes
Measure
Collection of clinical material and information
Timeframe
life of study
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).

Conditions
Multiple Myeloma
Study Contact
Name
Vaishali Sanchorawala, MD
Role
Contact
Phone
617-638-8261
Email
vaishali.sanchorawala@bmc.org
Name
Annie Jose, BS
Role
Contact
Phone
617 638 8213
Email
annie.jose@bmc.org
Locations
Facility

Boston University Cancer Research Center
Boston, MA 02118
United States

Contacts
Study Contact
Name
Clinical Trials Office - Boston University Cancer Research Cen
Phone
617-638-8265
Role
Contact
Eligibility Criteria

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

Eligibility Minimum Age
18 Years
Sexes Eligible for Study
ALL
Eligibility Std Ages
Adult
Older Adult
Study Population

Participants diagnosed, or with suspicion of having, amyloidosis