Analysis of the Role of IgE Proteoforms in Health and Disease

NCT ID: NCT07328178

Last Updated: 2026-01-09

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

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2029-01-01

Brief Summary

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The goal of this observational study is to evaluate the role of IgE proteoforms in healthy volunteers and in patients with type I allergy, patients with chronic spontaneous urticaria, patients with a recent history of anaphylaxis, patients with mastocytosis, patients with hereditary alpha tryptasemia, patients with X-linked agammaglobulinemia (XLA), and patients undergoing desensitization for venom or medication allergy.

Detailed Description

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Conditions

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Anaphylaxis Mastocytosis X-linked Agammaglobulinaemia Venom Allergy Chronic Spontaneous Urticaria (CSU) Type I Allergy Medication Allergy Healthy Control Hereditary Alpha-Tryptasemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy controls

Blood sample collection

Intervention Type OTHER

Blood sample collection

Patients with type I allergy

Including medication allergy, venom allergy, food allergy, allergic rhinitis

Blood sample collection

Intervention Type OTHER

Blood sample collection

Patients with chronic spontaneous urticaria

With or without omalizumab

Blood sample collection

Intervention Type OTHER

Blood sample collection

Patients with a recent history of anaphylaxis

In whom serial sampling can be performed

Blood sample collection

Intervention Type OTHER

Blood sample collection

Patients undergoing desensitization for venom allergy

Blood sample collection

Intervention Type OTHER

Blood sample collection

Patients undergoing desensitization for medication allergy

Blood sample collection

Intervention Type OTHER

Blood sample collection

Patients with mastocytosis

Blood sample collection

Intervention Type OTHER

Blood sample collection

Patients with hereditary alpha tryptasemia

Blood sample collection

Intervention Type OTHER

Blood sample collection

Patients with X-linked agammaglobulinemia (XLA)

Blood sample collection

Intervention Type OTHER

Blood sample collection

Interventions

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Blood sample collection

Blood sample collection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* CSU and type I allergic diseases (including anaphylaxis and desensitization), atopic dermatitis, mastocytosis, XLA and HaT (informed consent, age: any available adult subject, gender: any available subject, clinical phenotype and specific information about the allergy (e.g. severity, medication, medical history, laboratory testing)
* Healthy controls (informed consent, age matched to the allergic patients, gender matched to the allergic patients, patient-reported symptoms related to allergy to aeroallergens, food, drugs, hymenoptera venom, CSU)

Exclusion Criteria

* Absence of informed consent
* Age \< 18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Rik Schrijvers

Prof. Dr. Rik Schrijvers

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rik Schrijvers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ/KU Leuven

Locations

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UZ/KU Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Rik Schrijvers, MD, PhD

Role: primary

016342985

Dries Wets, MD

Role: backup

016338198

Other Identifiers

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S69940

Identifier Type: -

Identifier Source: org_study_id

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