Laboratory and Clinical Data in Antiphospholipid Patients (APSregistry)

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

To constitute a registry of antiphospholipid antibodies positive-patients

Study Overview

• Status: Recruiting
• Conditions: Antiphospholipid Syndrome
• Intervention / Treatment: Diagnostic test: Blood test

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Not yet recruiting
    • CHRU de Lille
    • Sub-Investigator: Marc Lambert, MD, PhD
    • Sub-Investigator: Cécile Yelnik, MD
  • Nancy, France
    • Recruiting
    • CHRU de NANCY
    • Sub-Investigator: Stéphane Zuily, MD, PhD
    • Contact: Denis Wahl, MD, PhD; Phone Number: +33383153614; Email: d.wahl@chru-nancy.fr
    • Principal Investigator: Denis Wahl, MD, PhD
    • Sub-Investigator: Virginie Dufrost, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Antiphospholipid antibodies positive-patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thrombosis	Rate of thrombosis	Up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding	Rate of bleeding	Up to 10 years

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Anticipated): April 1, 2030
• Study Completion (Anticipated): April 1, 2031

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): December 20, 2021
• Last Update Submitted That Met QC Criteria: December 17, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: antiphospholipid antibodies
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Antiphospholipid Syndrome
• Other Study ID Numbers: 2019-A02058-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No