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

May 18, 2026 updated by: Centre Hospitalier Universitaire de Nice

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06001
        • CHU de Nice - Hôpital de Pasteur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Samples Without DNA
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).
Genetic: 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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Leroy Sylvie, PhD, CHU de Nice, Service de Pneumologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2023

Primary Completion (Actual)

December 5, 2025

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

November 9, 2023

First Submitted That Met QC Criteria

November 14, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-AOI-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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