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

NCT06133907 | Recruiting

• 1 other identifier: 22-AOI-12
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Bronchiolitis

Outcome Measures

Primary Outcomes (1)

• Prevalence of hereditary hyper alpha-tryptasemia

  Analysis machine by PCR

  at inclusion

Secondary Outcomes (2)

• Phenotyping our patient cohort

  at 36 months

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

  At inclusion

Study Arms (1)

Samples Without DNA

EXPERIMENTAL

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

Interventions

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).

Samples Without DNA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• High tryptasemia (≥ 8ng/ml) synchronous with anaphylactic reaction and unconfirmed basally
• Known diagnosis of systemic mastocytosis

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - Hôpital de Pasteur

Nice, Alpes-Maritimes, 06001, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Leroy Sylvie, PhD

  CHU de Nice, Service de Pneumologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leroy Sylvie, PhD

CONTACT

+33492038580; leroy.s2@chu-nice.fr

Griffonnet Jennifer

CONTACT

+33492038281; griffonnet.j@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 18, 2023
• Study Start: December 5, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

FR (1)