Different forms of IgE in health and disease.
Analysis of the Role of IgE Proteoforms in Health and Disease
We will test whether different forms of IgE in the blood differ between healthy adults and people with allergies, chronic spontaneous urticaria, recent anaphylaxis, mastocytosis, hereditary alpha tryptasemia, X‑linked agammaglobulinemia, or those undergoing venom/medication desensitization.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT07328178 on ClinicalTrials.gov |
What this trial studies
This is an observational study that collects blood samples from adult patients with various IgE‑related conditions and from age‑ and gender‑matched healthy controls at UZ/KU Leuven. Researchers will profile IgE proteoforms (molecular variants of IgE) to compare patterns across clinical groups. Clinical history and laboratory information will be recorded to link proteoform patterns to disease features such as recent anaphylaxis or ongoing desensitization. No investigational treatments are given; the focus is molecular characterization of patient samples.
Who should consider this trial
Good fit: Adults (18 or older) who can give informed consent and who have CSU, type I allergic diseases including recent anaphylaxis or desensitization, atopic dermatitis, mastocytosis, hereditary alpha tryptasemia, X‑linked agammaglobulinemia, or age‑ and gender‑matched healthy controls are appropriate candidates.
Not a fit: People under 18 years old, those unable to give informed consent, or patients expecting direct therapeutic benefit from participation are unlikely to gain personal medical benefit from this observational protocol.
Why it matters
Potential benefit: If successful, the findings could identify IgE molecular patterns that improve diagnosis, risk stratification, or personalization of allergy and mast cell disease care.
How similar studies have performed: Related work on IgE variants and glycosylation has provided biological insights, but comprehensive proteoform profiling in these patient groups is still relatively novel and not yet proven to change clinical care.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Leuven, Vlaams-Brabant
- UZ/KU Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Rik Schrijvers, MD, PhD — UZ/KU Leuven
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.