- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04308564
Laboratory and Clinical Data in Antiphospholipid Patients (APSregistry)
December 17, 2021 updated by: Pr Denis WAHL, Central Hospital, Nancy, France
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thrombosis
Time Frame: Up to 10 years
|
Rate of thrombosis
|
Up to 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bleeding
Time Frame: Up to 10 years
|
Rate of bleeding
|
Up to 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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