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NCT Number: NCT04308564

Laboratory and Clinical Data in Antiphospholipid Patients

To constitute a registry of antiphospholipid antibodies positive-patients

Recruiting

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Key information

Conditions

Antiphospholipid Syndrome Autoimmune Diseases Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Lille, Lille, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age between 18 and 60 years;
  • persistent (at least 12 weeks apart) aPL-positivity within 12 months prior to screening

Exclusion criteria

  • no inform consent
  • impossible follow up
  • pregnancy

Treatment and study plan

Blood test

Diagnostic Test

Blood test for the identification of biomarkers

Primary outcomes

  1. Thrombosis

    Time frame: Up to 10 years

    Rate of thrombosis

Secondary outcomes

  1. Bleeding

    Time frame: Up to 10 years

    Rate of bleeding

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: APSregistry

Important dates

Study start
2021
Primary completion
2030
Study completion
2031
First posted
Mar 16, 2020
Registry last updated
Dec 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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