Analysis of the Role of IgE Proteoforms in Health and Disease

NCT07328178 | Recruiting DMC

• 1 other identifier: S69940
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Evaluation of IgE proteoforms

  4 years

Study Arms (9)

Healthy controls

Other: Blood sample collection

Patients with type I allergy

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

Other: Blood sample collection

Patients with chronic spontaneous urticaria

With or without omalizumab

Other: Blood sample collection

Patients with a recent history of anaphylaxis

In whom serial sampling can be performed

Other: Blood sample collection

Patients undergoing desensitization for venom allergy

Other: Blood sample collection

Patients undergoing desensitization for medication allergy

Other: Blood sample collection

Patients with mastocytosis

Other: Blood sample collection

Patients with hereditary alpha tryptasemia

Other: Blood sample collection

Patients with X-linked agammaglobulinemia (XLA)

Other: Blood sample collection

Interventions

Blood sample collection OTHER

Blood sample collection

Healthy controls; Patients undergoing desensitization for medication allergy; Patients undergoing desensitization for venom allergy; Patients with X-linked agammaglobulinemia (XLA); Patients with a recent history of anaphylaxis; Patients with chronic spontaneous urticaria; Patients with hereditary alpha tryptasemia; Patients with mastocytosis; Patients with type I allergy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type I allergy (including medication allergy, venom allergy, food allergy, allergic rhinitis), patients with chronic spontaneous urticaria (with or without omalizumab), patients with a recent history of anaphylaxis in whom serial sampling can be performed, patients undergoing desensitization for venom allergy, patients undergoing desensitization for medication allergy, patients with mastocytosis, patients with hereditary alpha tryptasemia, patients with X-linked agammaglobulinemia (XLA), healthy controls

You may qualify if:

• 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)

You may not qualify if:

• Absence of informed consent
• Age \< 18 years old

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

UZ/KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Anaphylaxis; Mastocytosis; Bruton type agammaglobulinemia; Venom Hypersensitivity; Chronic Urticaria; Drug Hypersensitivity; Hereditary alpha-tryptasemia syndrome

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Mast Cell Activation Disorders; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Rik Schrijvers, MD, PhD

  UZ/KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Rik Schrijvers

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 9, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 9, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)