NCT04308564

Laboratory and Clinical Data in Antiphospholipid Patients

Constitution d'Une Collection d'Echantillons Biologiques Associee a Une Base de Donnees de Patients Possedant Des Anticorps Antiphospholipides

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To constitute a registry of antiphospholipid antibodies positive-patients

Detailed description

An international web-based application, the REDCap (Research Electronic Data Capture), captures data on patient demographics, aPL-related clinical and laboratory characteristics, and medications. The inclusion criteria are: a) age between 18 and 60 years; and b) persistent (at least 12 weeks apart) aPL-positivity within 12 months prior to screening; positivity is defined as anticardiolipin antibodies (aCL) IgG/M/A (\> 40 GPL/MPL/APL, medium-to-high titer, and/or greater than the 99th percentile), anti-β2-glycoprotein-I (aβ2GPI) IgG/M/A (\> 40 units, medium-to-high titer), positive lupus anticoagulant (LA) test based on International Society on Thrombosis and Hemostasis and other current guidelines. Patients are followed every 12 ± 3 months with clinical data and blood collection. Blood drawn is done at inclusion and every year.

Conditions

• Antiphospholipid Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood test	Blood test for the identification of biomarkers

Timeline

• Start date: 2021-04-12
• Primary completion: 2030-04-01
• Completion: 2031-04-01
• First posted: 2020-03-16
• Last updated: 2021-12-20

Locations

2 sites across 1 country: France