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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06133907

Acronym

HaT

Enrollment

100

Registered

2023-11-18

Start date

2023-12-05

Completion date

2026-12-01

Last updated

2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Bronchiolitis

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.

Interventions

GENETICSerum

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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Prevalence of hereditary hyper alpha-tryptasemia	at inclusion	Analysis machine by PCR

Secondary

Measure	Time frame	Description
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

Countries

France

Contacts

Primary ContactLeroy Sylvie, PhD

leroy.s2@chu-nice.fr+33492038580

Backup ContactGriffonnet Jennifer

griffonnet.j@chu-nice.fr+33492038281

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026