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

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06133907
Collaborator
(none)
100
Enrollment
1
Arm
36
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Serum
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Investigation of the Frequency of Hereditary Hyper Alpha-tryptasemia in Patients With Elevated Basal Tryptasemia (Protocol HaT)
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Prevalence of hereditary hyper alpha-tryptasemia [at inclusion]

    Analysis machine by PCR

Secondary Outcome Measures

  1. Phenotyping our patient cohort [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 [At inclusion]

    Biobanking

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT06133907
Other Study ID Numbers:
  • 22-AOI-12
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Bronchiolitis

Study Results

No Results Posted as of Nov 18, 2023