Study of Systemic Amyloidosis Presentation and Prognosis

This study is currently recruiting participants.

Verified by National Center for Research Resources (NCRR), December 2003

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Indiana University School of Medicine
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00004374

Purpose

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.

Condition
Amyloidosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening
Official Title:	Study of Systemic Amyloidosis Presentation and Prognosis

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment:	100
Study Start Date:	January 1979

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004374

Locations

United States, Indiana
Indiana University Cancer Center	Recruiting
Indianapolis, Indiana, United States, 46202-5265
Contact: Merrill D. Benson 317-278-3426

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Indiana University School of Medicine

Investigators

Study Chair:

Merrill D. Benson

Indiana University School of Medicine

More Information

No publications provided

Study ID Numbers:	NCRR-M01RR00750-0062, IUSM-831215
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004374 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):

amyloidosis
arthritis & connective tissue diseases
genetic diseases and dysmorphic syndromes
rare disease

Study placed in the following topic categories:

Amyloidosis
Metabolic Diseases
Arthritis

Rare Diseases
Connective Tissue Diseases
Metabolic Disorder

Additional relevant MeSH terms:

Amyloidosis
Metabolic Diseases

ClinicalTrials.gov processed this record on May 07, 2009