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Study of Systemic Amyloidosis Presentation and Prognosis
This study is currently recruiting participants.
Study NCT00004374   Information provided by National Center for Research Resources (NCRR)
First Received: October 18, 1999   Last Updated: June 23, 2005   History of Changes

October 18, 1999
June 23, 2005
January 1979
 
 
 
Complete list of historical versions of study NCT00004374 on ClinicalTrials.gov Archive Site
 
 
 
Study of Systemic Amyloidosis Presentation and Prognosis
Study of Systemic Amyloidosis Presentation and Prognosis

OBJECTIVES: I. Analyze prospectively the course of amyloid deposition in patients with primary, secondary, myeloma-associated, and hereditary amyloidosis.

II. Determine abnormalities of humoral and delayed-type hypersensitivity in these patients.

III. Identify prognostic factors in hereditary amyloidosis and develop tests for genetic defects associated with systemic amyloidosis.

IV. Diagnose familial amyloidotic polyneuropathy (FAP) prior to symptom onset. V. Validate the correlation of low serum prealbumin and retinol binding protein levels with amyloidosis in patients with FAP.

PROTOCOL OUTLINE: Patients receive a comprehensive evaluation with an emphasis on identifying prognostic and diagnostic factors. Assessments include gastrointestinal, renal, hematologic, dermatologic, cardiac, and serologic studies. Immunologic studies include antinuclear antibody, latex fixation, and serum and urine electrophoresis.

Genetic trees are constructed using detailed family history data; blood and urine samples are routinely collected from relatives. Family members of patients with familial amyloidotic polyneuropathy type II (Indiana type) undergo a flexor retinaculum biopsy of the wrist.

 
Observational
Screening
Amyloidosis
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
 
 

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Systemic amyloidosis, i.e.: Primary, myeloma associated Secondary, e.g., associated with the following conditions: Rheumatoid arthritis Inflammatory bowel disease

Both
 
No
 
United States
 
NCT00004374
 
NCRR-M01RR00750-0062, IUSM-831215
National Center for Research Resources (NCRR)
Indiana University School of Medicine
Study Chair: Merrill D. Benson Indiana University School of Medicine
National Center for Research Resources (NCRR)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP