Laboratory and Clinical Data in Antiphospholipid Patients | NCT04308564

Studies
Laboratory and Clinical Data in Antiphospholipid Patients

NCT04308564

Sponsor

Central Hospital, Nancy, France

Status

Recruiting

Last Update Posted

Dec 20, 2021Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Antiphospholipid Syndrome

Interventions

Blood test

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2021Actual

Primary Completion Date

Apr 1, 2030Estimated

Completion Date

Apr 1, 2031Estimated

First Submitted Date

Mar 9, 2020

First Submission Date that Met QC Criteria

Mar 11, 2020

First Posted Date

Mar 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2021

Last Update Posted Date

Dec 20, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pr Denis WAHL, Head of Vascular Medicine Division, Principal Investigator, Professor of Vascular Medicine, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood test	Diagnostic Test	Blood test for the identification of biomarkers

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Antiphospholipid antibodies positive-patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Lille	Not yet recruiting	Lille			France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016736	Antiphospholipid Syndrome

Ancestor Terms

ID	Term
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided