Long-Term Outcome of Children and Adolescents With Anti-Phospholipid Antibodies
NCT ID: NCT00581763
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
110 participants
OBSERVATIONAL
2001-05-31
2019-12-20
Brief Summary
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Detailed Description
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1. Determine the incidence, and time frame, for aquiring aPL in a cohort of aPL-negative pediatric SLE subjects.
2. Determine the incidence, and time frame, for developing a first APS-associated complication among SLE subjects with detectable aPL.
3. Determine the incidence, and time frame, for developing a second APS-associated event among subjects with a history of an APS-associated event.
4. Determine the incidence, and time frame, for developing SLE among subjects with a history of an APS-associated event in the absence of SLE.
5. 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observation
Those with a condition
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Emily von Scheven
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Other Identifiers
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H8994-19045
Identifier Type: -
Identifier Source: org_study_id