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Study of Systemic Amyloidosis Presentation and Prognosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Indiana University School of Medicine
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00004374
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: December 2003
History of Changes
  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

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

Resource links provided by NLM:

MedlinePlus related topics: Amyloidosis
U.S. FDA Resources

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

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

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013