NCT04308564

Brief Summary

To constitute a registry of antiphospholipid antibodies positive-patients

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
58mo left

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress52%
Apr 2021Apr 2031

First Submitted

Initial submission to the registry

March 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 12, 2021

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2031

Last Updated

December 20, 2021

Status Verified

December 1, 2021

Enrollment Period

9 years

First QC Date

March 9, 2020

Last Update Submit

December 17, 2021

Conditions

Antiphospholipid Syndrome

Keywords

antiphospholipid antibodies

Outcome Measures

Primary Outcomes (1)

  • Thrombosis

    Rate of thrombosis

    Up to 10 years

Secondary Outcomes (1)

  • Bleeding

    Up to 10 years

Interventions

Blood testDIAGNOSTIC_TEST

Blood test for the identification of biomarkers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Antiphospholipid antibodies positive-patients

You may qualify if:

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

You may not qualify if:

  • no inform consent
  • impossible follow up
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Lille

Lille, France

NOT YET RECRUITING

CHRU de Nancy

Nancy, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA, plasma and serum

MeSH Terms

Conditions

Antiphospholipid Syndrome

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Vascular Medicine Division, Principal Investigator, Professor of Vascular Medicine

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 16, 2020

Study Start

April 12, 2021

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2031

Last Updated

December 20, 2021

Record last verified: 2021-12

Locations

FR(2)