AmyloidosisNCT00004374
Study of Systemic Amyloidosis Presentation and Prognosis
An observational study of Amyloidosis, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Amyloidosis
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1979to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
Merrill D. Benson, 317-278-3426
About this study
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.
Read the 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.
- Conditions
- Amyloidosis
- Keywords
- amyloidosis, arthritis & connective tissue diseases, genetic diseases and dysmorphic syndromes, rare disease
- Medical subject headings
- Amyloidosis, Arthritis, Connective Tissue Diseases, Genetic Diseases, Inborn, Rare Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startJan 1979
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Indiana University
- Investigators
- Merrill D. Benson, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004374
- Sponsor's protocol ID
- NCRR-M01RR00750-0062
- Other IDs
- IUSM-831215
- Status last verified
- Dec 2003
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Systemic Amyloidosis Presentation and Prognosis
- ClinicalTrials.gov ID
- NCT00004374
- Acronym / sponsor ID
- NCRR-M01RR00750-0062
- Conditions
- Amyloidosis
- Keywords
- amyloidosis, arthritis & connective tissue diseases, genetic diseases and dysmorphic syndromes, rare disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Indiana University
- Study start
- Jan 1979
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merrill D. Benson study chair
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyloidosis, run by National Center for Research Resources (NCRR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.