Study of Systemic Amyloidosis Presentation and Prognosis
Recruitment status was: Recruiting
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.
|Study Design:||Primary Purpose: Screening|
|Official Title:||Study of Systemic Amyloidosis Presentation and Prognosis|
|Study Start Date:||January 1979|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004374
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5265|
|Study Chair:||Merrill D. Benson||Indiana University School of Medicine|