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NCT Number: NCT06133907

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Allergic Bronchiolitis Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice - Hôpital de Pasteur

Nice, Alpes-Maritimes, 06001, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serum

Genetic

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 outcomes

  1. Prevalence of hereditary hyper alpha-tryptasemia

    Time frame: at inclusion

    Analysis machine by PCR

Secondary outcomes

  1. 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.

  2. Set up a serotheque to support scientific and medical projects in this field

    Time frame: At inclusion

    Biobanking

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: HaT

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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