NCT00581763

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 28, 2007

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

18.6 years

First QC Date

December 19, 2007

Last Update Submit

December 23, 2024

Conditions

Lupus

Outcome Measures

Primary Outcomes (1)

  • thrombosis

    blood clot

    Ten years

Secondary Outcomes (1)

  • lupus

    10 years

Study Arms (1)

Observation

Those with a condition

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young group of SLE and APS subjects

You may qualify if:

  • 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.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum

Study Officials

  • Emily von Scheven

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 28, 2007

Study Start

May 1, 2001

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations

US(1)