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| Tracking Information | |||||
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| First Received Date ICMJE | October 18, 1999 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | January 1979 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00004374 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Systemic Amyloidosis Presentation and Prognosis | ||||
| Official Title ICMJE | Study of Systemic Amyloidosis Presentation and Prognosis | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Screening | ||||
| Condition ICMJE | Amyloidosis | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00004374 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | NCRR-M01RR00750-0062, IUSM-831215 | ||||
| Study Sponsor ICMJE | National Center for Research Resources (NCRR) | ||||
| Collaborators ICMJE | Indiana University School of Medicine | ||||
| Investigators ICMJE |
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| Information Provided By | National Center for Research Resources (NCRR) | ||||
| Verification Date | December 2003 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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