Association of TNFAIP3 With Immune-mediated TTP

NCT ID: NCT06928233

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-04

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Thrombotic Thrombocytopenic Purpura, Acquired

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patients with iTTP

Intervention: blood sampling during standard collection for routine testing, with additional sample for experimental analyses.

Group Type OTHER

blood sampling

Intervention Type PROCEDURE

Blood sampling for experimental analyses.

Healthy donors

Intervention: blood sampling during standard donation, with an additional sample collected for experimental analyses.

Group Type OTHER

blood sampling

Intervention Type PROCEDURE

Blood sampling for experimental analyses.

Interventions

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blood sampling

Blood sampling for experimental analyses.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of iTTP
* Above 12 years of age
* Caucasian, Italian origin
* Written informed consent to participate in the study

Exclusion Criteria

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

Controls will be healthy Italian volunteers of Caucasian ethnicity, with no history of thrombotic thrombocytopenic purpura, frequency-matched to cases by age and sex, and who have provided written informed consent to participate in the study.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Responsible Party

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Ilaria Mancini

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ilaria Mancini, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Locations

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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2022-0469

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

A20iTTP

Identifier Type: -

Identifier Source: org_study_id

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