Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373003
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-15
Brief Title:
Negative Antiphospholipid Syndrome a Multicentric Study
Sponsor:
Italian Society for Rheumatology
Organization:
Italian Society for Rheumatology
Study Overview
Official Title:
Negative Antiphospholipid Syndrome a Multicentric Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multicentre no-profit national cross-sectional diagnostic retrospective study promoted by the Italian Society for Rheumatology
The main objective of the study is to assess the diagnostic accuracy of non-criteria aPL anti-vimentincardiolipin and anti-phosphatidylserineprothrombin in identifying APS in patients with thrombosisrecurrent adverse pregnancy outcomes
The main objective of the study is to assess the diagnostic accuracy of non-criteria aPL anti-vimentincardiolipin and anti-phosphatidylserineprothrombin in identifying APS in patients with thrombosisrecurrent adverse pregnancy outcomes
Detailed Description:
BACKGROUND Antiphospholipid syndrome APS is an autoimmune disorder leading to arterial andor venous thrombotic events and pregnancy morbidity Seronegative antiphospholipid syndrome SN-APS occurs in case of clinical manifestations highly suggestive of APS but with negative test for circulating conventional antiphospholipid antibodies anticardiolipin antibodies anti-beta-I-glycoprotein antibodies lupus anticoagulant Recent studies have shown that most SN-APS patients present circulating non-criteria antibodies potentially explaining the clinical manifestations In a smaller proportion of SN-APS patients no antibody has been detected so far Available knowledge on the clinical presentation and disease course of SN-APS is limited and the causal relationship between non-criteria antibodies and recurrent thrombosis deserves further research to be confirmed To date no difference between APS and SN-APS groups has been highlighted in terms of thrombotic events or pregnancy morbidity but this could be in part explained by small samples not sufficiently powered to detect a difference Moreover it is still to determine whether the detection of non-criteria antibodies in addition to conventional aPL may help stratify patients according to their risk of clinical manifestationA multicentre study involving Italian centres could allow to investigate the diagnostic accuracy of no-criteria aPL and elucidate the prognostic impact of such antibodies alone or in combination with criteria aPL In addition a multicentre study could allow to study a larger sample of patients and better quantify poorly investigated aspects in SN-APS
MAIN OBJECTIVE To assess the diagnostic accuracy of non-criteria aPL anti-vimentincardiolipin and anti-phosphatidylserineprothrombin in identifying APS in patients with thrombosisrecurrent adverse pregnancy outcomes group 1 vs group 3 see below
SECONDARY OBJECTIVES
To assess the diagnostic accuracy of non-criteria aPL in identifying SN-APS in patients with thrombosisrecurrent adverse pregnancy outcomes group 2 vs group 3
To compare the clinical characteristics of APS vs SN-APS in patients with and without non-criteria aPL
To estimate the association between different aPL status on the recurrence of thrombosisadverse pregnancy outcomes
EXPLORATORY OBJECTIVE To assess the prevalence of anti-cardiolipin antibodies aCL by thin-layer chromatography TLC-immunostaining anti-carbamylated-β2-glycoprotein I antibodies and Anti-glucose-modified β2 glycoprotein I antibodies in APS and SN-APS groups group 1 and group 2
SAMPLE SIZE AND STUDY PROCEDURES A minimum sample size of 35 patients for each group is planned for this study
LABORATORY PROCEDURES Blood samples will be collected and analysed in each recruiting centre as routine practice at 12 weeks apart The laboratory tests for the non-criteria aPL will be centrally performed at the Department of Experimental Medicine Umberto I Polyclinic in Rome
STUDY DURATION Enrolment 24 months starting from the first patient recruited Analysis and reporting 12 months starting from the end of the enrollment
STUDY SCHEME The study can be divided into three phases i the collection of all clinical data at the onset of the thrombotic or obstetric event ii the collection of all the clinical data between the first clinical event and the patient recruitment iii the detection of non-criteria aPL from the patients blood samples The first two phases characterise the retrospective part of the study while the third phase characterises the cross-sectional part of the study
In phase 1 the following data associated with the clinical event will be collected relevant demographic data the history of all criteria events the history of all non-criteria events all relevant risk factors the history of pharmacological treatments before or in progress at the clinical event and the collection of laboratory data available at the diagnosis Phase 1 data will be collected by all participating centres
In phase 2 new criteria events non-criteria manifestations related to the clinical events and risk factors developed between the first clinical event and the date of recruitment of a patient will be assessed Phase 2 data will be collected by all participating centres
In phase 3 patients blood samples will be tested at the coordinating centre to evaluate the presence of non-criteria aPL Two blood samples will be collected by each patient recruited by a centre such samples should be primarily retrieved from those previously collected by a centre at the time of diagnosisherein serum library and stored at the centre itself in case of their absence blood samples can be collected from a recruited patient upon enrolment In case only one sample can be retrieved from the hospital serum library the remaining one will be collected from the recruited patient Blood samples taken from deceased patients will be excluded
STATISTICAL ANALYSIS Baseline characteristics will be summarized by descriptive statistics The accuracy of non-criteria aPL index test in discriminating between cases and controls reference standard will be estimated as sensitivity and specificity
A first analysis will use APS criteria cases group 1 and controlsgroup 3 as non-cases a second analysis will use SN-APS group 2 as cases and controls group 3 as non-cases
The following groups APS group 1 SN-APS group 2 subdivided into positive for non-criteria aPL and negative for non-criteria and controls group 3 will be compared for clinical characteristics treatment variables
A logistic regression model considering the recurrent event as outcome and the APS status groups 1 2 and 3 as predictor adjusted for demographic event type and treatment will be performed
MAIN OBJECTIVE To assess the diagnostic accuracy of non-criteria aPL anti-vimentincardiolipin and anti-phosphatidylserineprothrombin in identifying APS in patients with thrombosisrecurrent adverse pregnancy outcomes group 1 vs group 3 see below
SECONDARY OBJECTIVES
To assess the diagnostic accuracy of non-criteria aPL in identifying SN-APS in patients with thrombosisrecurrent adverse pregnancy outcomes group 2 vs group 3
To compare the clinical characteristics of APS vs SN-APS in patients with and without non-criteria aPL
To estimate the association between different aPL status on the recurrence of thrombosisadverse pregnancy outcomes
EXPLORATORY OBJECTIVE To assess the prevalence of anti-cardiolipin antibodies aCL by thin-layer chromatography TLC-immunostaining anti-carbamylated-β2-glycoprotein I antibodies and Anti-glucose-modified β2 glycoprotein I antibodies in APS and SN-APS groups group 1 and group 2
SAMPLE SIZE AND STUDY PROCEDURES A minimum sample size of 35 patients for each group is planned for this study
LABORATORY PROCEDURES Blood samples will be collected and analysed in each recruiting centre as routine practice at 12 weeks apart The laboratory tests for the non-criteria aPL will be centrally performed at the Department of Experimental Medicine Umberto I Polyclinic in Rome
STUDY DURATION Enrolment 24 months starting from the first patient recruited Analysis and reporting 12 months starting from the end of the enrollment
STUDY SCHEME The study can be divided into three phases i the collection of all clinical data at the onset of the thrombotic or obstetric event ii the collection of all the clinical data between the first clinical event and the patient recruitment iii the detection of non-criteria aPL from the patients blood samples The first two phases characterise the retrospective part of the study while the third phase characterises the cross-sectional part of the study
In phase 1 the following data associated with the clinical event will be collected relevant demographic data the history of all criteria events the history of all non-criteria events all relevant risk factors the history of pharmacological treatments before or in progress at the clinical event and the collection of laboratory data available at the diagnosis Phase 1 data will be collected by all participating centres
In phase 2 new criteria events non-criteria manifestations related to the clinical events and risk factors developed between the first clinical event and the date of recruitment of a patient will be assessed Phase 2 data will be collected by all participating centres
In phase 3 patients blood samples will be tested at the coordinating centre to evaluate the presence of non-criteria aPL Two blood samples will be collected by each patient recruited by a centre such samples should be primarily retrieved from those previously collected by a centre at the time of diagnosisherein serum library and stored at the centre itself in case of their absence blood samples can be collected from a recruited patient upon enrolment In case only one sample can be retrieved from the hospital serum library the remaining one will be collected from the recruited patient Blood samples taken from deceased patients will be excluded
STATISTICAL ANALYSIS Baseline characteristics will be summarized by descriptive statistics The accuracy of non-criteria aPL index test in discriminating between cases and controls reference standard will be estimated as sensitivity and specificity
A first analysis will use APS criteria cases group 1 and controlsgroup 3 as non-cases a second analysis will use SN-APS group 2 as cases and controls group 3 as non-cases
The following groups APS group 1 SN-APS group 2 subdivided into positive for non-criteria aPL and negative for non-criteria and controls group 3 will be compared for clinical characteristics treatment variables
A logistic regression model considering the recurrent event as outcome and the APS status groups 1 2 and 3 as predictor adjusted for demographic event type and treatment will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None