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

Not Applicable

Recruiting

• Conditions: Allergic Bronchiolitis
• Interventions: Genetic: Serum

• Registration Number: NCT06133907
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-18
• Study Start: 2023-12-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Samples Without DNA	Serum	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).

Primary Outcome Measures

Name	Time	Method
Prevalence of hereditary hyper alpha-tryptasemia	at inclusion	Analysis machine by PCR

Secondary Outcome Measures

Name	Time	Method
Phenotyping our patient cohort	at 36 months	longitudinal follow-up of clinical symptoms according to patient subgroups in relation to mast cell pathologies.
Set up a serotheque to support scientific and medical projects in this field	At inclusion	Biobanking

Trial Locations

Locations (1)

CHU de Nice - Hôpital de Pasteur; 🇫🇷 Nice, Alpes-Maritimes, France