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RecruitingNCT04308564APSregistryUpdated Dec 20, 2021

Laboratory and Clinical Data in Antiphospholipid Patients

An observational study in Antiphospholipid Syndrome, sponsored by Central Hospital, Nancy, France. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-20.

Sponsored by Central Hospital, Nancy, France · Observational

From the registry’s dates

  • Started Apr 2021; still recruiting 5 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

To constitute a registry of antiphospholipid antibodies positive-patients

Read the 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.

02

Conditions studied

  • Antiphospholipid Syndrome

Keywords

  • antiphospholipid antibodies
03

In context

Antiphospholipid Syndrome

121 studies on the registry are indexed under Antiphospholipid Syndrome; 51 are open to participants now.

This study's planned enrollment of 60 is below the median of 181 across 52 observational studies indexed under Antiphospholipid Syndrome.

Browse Antiphospholipid Syndrome studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Antiphospholipid antibodies positive-patients

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • no inform consent
  • impossible follow up
  • pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Interventions

  • Diagnostic testBlood test

    Blood test for the identification of biomarkers

06

What researchers measure

Primary outcomes

  1. Thrombosis

    Rate of thrombosis

    Time frame: Up to 10 years

Secondary outcomes

  1. Bleeding

    Rate of bleeding

    Time frame: Up to 10 years

07

Study locations

1 of 2 sites recruiting
  • CHRU de Lille
    Lille, France
    • Eric Hachulla · Contact
    • Eric Hachulla, MD, PhD · Principal investigator
    • Marc Lambert, MD, PhD · Sub investigator
    • Cécile Yelnik, MD · Sub investigator
    Not yet recruiting
  • CHRU de Nancy
    Nancy, France
    • Denis Wahl, MD, PhD · Contact · d.wahl@chru-nancy.fr · +33383153614
    • Denis Wahl, MD, PhD · Principal investigator
    • Stéphane Zuily, MD, PhD · Sub investigator
    • Virginie Dufrost, MD, MSc · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04308564
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Pr Denis WAHL (Head of Vascular Medicine Division, Principal Investigator, Professor of Vascular Medicine, Central Hospital, Nancy, France) — Principal investigator
First posted
Mar 16, 2020
Start date
Apr 12, 2021
Primary completion
Apr 1, 2030 (estimated)
Completion
Apr 1, 2031 (estimated)
Last update
Dec 20, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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