Clinical trial · Observational
Serum Basal Tryptase Levels in Healthy Children
Evaluation of Basal Tryptasemia According to Age in a Pediatric Control Population
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The National REference Center for MASTocytosis (CEREMAST), located at the Necker-Enfants Malades Hospital, is particularly interested in two groups of rare diseases whose common point is excessive activation of mast cells: mastocytosis and mast cell activation syndromes (MCAS). Unlike MCAS, whose symptoms result solely from this aberrant mast cell activation, in mastocytosis there is, in addition, an expansion and a clonal accumulation of mast cells in different target organs. These two diseases are heterogeneous in their clinical presentation and can begin in early childhood. While the diagnostic criteria for mastocytosis are well established, those for MCAS are unclear, causing major diagnostic error and therefore poor patient care. To date, there is no study evaluating tryptase standards in children less than 18 years of age. The research focuses on the dosage of tryptase in a control population of children aged 0 to 18 years. Each patient receiving a complete blood count (CBC) in a surgery department of the Necker-Enfants Malades hospital will be selected to participate in the study. After the CBC analysis, the rest of the sample will be kept for this research instead of being discarded. Knowing the norms of tryptase according to age would be an important tool for dermatologists, allergists and pediatricians caring for patients suspected of MCAS or mastocytosis. A blood test could thus avoid a few years of diagnostic wandering in the MCAS and mastocytosis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Tryptasemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tryptase dosage | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Subjects
- description
- Control pediatric population: no excess of chronic inflammatory or allergic disease compared to the general French population.
- interventionNames
- Other: Tryptase dosage
Primary outcomes (1)
- measure
- Serum basal tryptase levels according to age
- timeFrame
- 8 months
- description
- Basal tryptasemia according to age in a pediatric control population.
Secondary outcomes (1)
- measure
- Serum basal tryptasemia levels according to sex
- timeFrame
- 8 months
- description
- Basal tryptasemia according to sex in a pediatric control population.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Minor patients aged 0-18 * Patient for whom a complete blood count (CBC) is carried out for their care in a surgery department (orthopedic, visceral, maxillofacial, neurology, cardiology surgery) at the Necker-Enfants Malades hospital * Information and non-opposition of the subjects and of holders of parental authority subjects Exclusion Criteria: \- Patients hospitalized in departments other than surgery at Necker-Enfants Malades Hospital
References
Publications (1)
- RESULTPuel M, Rossignol J, Devin C, Madrange M, Diep A, Roland PN, Chollet-Martin S, Husson J, Hermine O, Bodemer C, Brouzes C, De Chaisemartin L, Polivka L; CEREMAST network. Redefining tryptase norms in the pediatric population reveals sex-based differences: Clinical implications. Allergy. 2025 Jan;80(1):335-338. doi: 10.1111/all.16365. Epub 2024 Oct 19. No abstract available. PMID 39425617