Investigating hereditary hyper-alpha-tryptasemia in patients with high tryptase levels
Investigation of the Frequency of Hereditary Hyper Alpha-tryptasemia in Patients With Elevated Basal Tryptasemia (Protocol HaT)
This study is testing how common a genetic condition that causes high tryptase levels is among patients with elevated tryptase, to help doctors better manage their care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice, Alpes-Maritimes) |
| Trial ID | NCT06133907 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the prevalence of hereditary hyper-alpha-tryptasemia in patients who present with elevated blood tryptase levels. Participants will be recruited from the pneumoallergology department at CHU de Nice and will undergo blood sampling to test for this hereditary condition. The results will help optimize the management and follow-up of patients who have experienced hypersensitivity reactions linked to elevated tryptase levels. Patients will receive their results during a follow-up medical consultation at the center.
Who should consider this trial
Good fit: Ideal candidates include patients who have undergone allergological workup at CHU de Nice and have had at least one basal tryptase assay.
Not a fit: Patients with high tryptasemia associated with anaphylactic reactions or those with a known diagnosis of systemic mastocytosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with hypersensitivity reactions and elevated tryptase levels.
How similar studies have performed: While this specific investigation may be novel, similar studies assessing hereditary conditions related to tryptase levels have shown promise in understanding allergic reactions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nice, Alpes-Maritimes
- CHU de Nice - Hôpital de Pasteur — Nice, Alpes-Maritimes, France (Recruiting)
Study contacts
- Principal investigator: Leroy Sylvie, PhD — CHU de Nice, Service de Pneumologie
- Study coordinator: Leroy Sylvie, PhD
- Email: leroy.s2@chu-nice.fr
- Phone: +33492038580
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.