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Association of TNFAIP3 With Immune-mediated TTP

ConditionThrombotic Thrombocytopenic Purpura, Acquired
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

About this trial

This study aims to investigate whether genetic variation in the TNFAIP3 locus is associated with immune-mediated thrombotic thrombocytopenic purpura (iTTP), and whether such association is mediated by decreased expression of A20 (TNFAIP3). The study includes a case-control design to assess genotype-expression association and a cohort study to evaluate clinical outcomes such as disease relapse.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosis of iTTP

Above 12 years of age

Caucasian, Italian origin

Written informed consent to participate in the study

Disqualifiers

Patients who do not meet the above-listed criteria will be excluded from participation in the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • blood sampling

    Procedure/Surgery

    Blood sampling for experimental analyses.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Patients with iTTPOther 1 intervention
Group B: Healthy donorsOther 1 intervention

Trial outcomes

Primary outcomes

1

Allele frequency of TNFAIP3 variants in cases vs controls

Time frame
Baseline

Secondary outcomes

1

TNFAIP3 (A20) mRNA expression levels in peripheral blood

TNFAIP3 (A20) mRNA expression levels in peripheral blood of cases versus controls

Time frame
Baseline
2

Association between TNFAIP3 genotype and gene expression

Time frame
Baseline
3

Clinical relapse rate of iTTP during follow-up

Association between TNFAIP3/A20 variation and iTTP relapse in iTTP patients

Time frame
Baseline
4

Severity of acute iTTP episodes

Association between TNFAIP3/A20 variation and the severity of acute iTTP (composite endpoint including death, treatment refractoriness, exacerbation, and prolonged disease course)

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Lead sponsor

Source ClinicalTrials.gov
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