Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004374
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Study of Systemic Amyloidosis Presentation and Prognosis
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
Study of Systemic Amyloidosis Presentation and Prognosis
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IUSM-831215 | None | None | None |