Investigation of the Frequency of Hereditary Hyper Alpha-tryptasemia in Patients With Elevated Basal Tryptasemia (HaT)

Centre Hospitalier Universitaire de Nice

Status: Enrolling

Conditions: Allergic Bronchiolitis

Treatments: Genetic: Serum

Study type: Interventional

Funder types: Other

Identifiers

NCT06133907

22-AOI-12

Details and patient eligibility

About

The aim of the study is to assess the number of patients with elevated blood tryptase for whom this elevation could be linked to a hereditary alpha-tryptase secretion abnormality or hyper-alpha-tryptasemia. This information will enable to better optimize the management and follow-up of patients who have experienced hypersensitivity reactions and have elevated basal blood tryptase levels. The patients will be offered the opportunity to take part in the study. If they consent to participate, they will be tested for hereditary hyper-alpha-tryptasemia. A blood sampling will be performed in the center. A few weeks after, the patient will be informed about the blood sample result during a medical consultation organized in the center.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who came in the pneumoallergology department of the CHU de Nice since January 2014 for an allergological workup
• Patients who have received at least one basal tryptase assay, according to recommendations
• informed consent signature

Exclusion criteria

• High tryptasemia (≥ 8ng/ml) synchronous with anaphylactic reaction and unconfirmed basally
• Known diagnosis of systemic mastocytosis

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Samples Without DNA

Experimental group

Description:

Patients who came to the pneumoallergology department of the CHU de Nice since January 2014 for an allergological workup and with tryptasemia was ≥ 8ng/ml (at least once in patient history).

Treatment:

Genetic: Serum