- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00581763
Long-Term Outcome of Children and Adolescents With Anti-Phospholipid Antibodies (APL)
June 11, 2012 updated by: University of California, San Francisco
This is a study about why some people have certain types of proteins in their blood, called anti-phospholipid antibodies.
The presence of these antibodies and associated complications (e.g.
blood clots) are known to change over time.
The purpose of this study is to evaluate these changes and improve our ability to determine the long-term outcome of affected individuals.
Study Overview
Status
Completed
Conditions
Detailed Description
Aim:
- Determine the incidence, and time frame, for aquiring aPL in a cohort of aPL-negative pediatric SLE subjects.
- Determine the incidence, and time frame, for developing a first APS-associated complication among SLE subjects with detectable aPL.
- Determine the incidence, and time frame, for developing a second APS-associated event among subjects with a history of an APS-associated event.
- Determine the incidence, and time frame, for developing SLE among subjects with a history of an APS-associated event in the absence of SLE.
- Identify laboratory and clinical predictors for the events described in aims 1-4.Research Design and Methods:
This is a prospective cohort study to determine the risk of developing aPL or APS-related symptoms in a young group of SLE and APS subjects. Patients will be followed over a ten year period and will undergo annual serologic and clinical evaluations to identify disease progression.
Study Type
Observational
Enrollment (Actual)
110
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- University of California, San Francisco
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Young group of SLE and APS subjects
Description
Inclusion Criteria:
Age: Less than 21 years at baseline exam
- Diagnosis: patients must meet criteria for one of five diagnostic categories based on classification according to three parameters; aPL positivity, APS criteria, and SLE criteria.
The five diagnostic categories are:
- SLE with no aPL
- SLE with aPL, but without manifestations of APS
- SLE-like APS
- SLE with APS
- Primary APS.
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Observation
Those with a condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate changes and improve ability to determine the long-term outcome of affected individuals
Time Frame: Ten years
|
Ten years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Emily von Scheven, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2001
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
December 19, 2007
First Submitted That Met QC Criteria
December 19, 2007
First Posted (Estimate)
December 28, 2007
Study Record Updates
Last Update Posted (Estimate)
June 13, 2012
Last Update Submitted That Met QC Criteria
June 11, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- H8994-19045
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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