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Serum Basal Tryptase Levels in Healthy Children

NCT05323188 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 402

Last updated 2025-09-12

No results posted yet for this study

Summary

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

  • Basal Tryptasemia

Interventions

OTHER

Tryptase dosage

Collection of biological waste from a blood test for complete blood count (CBC) of care. Centrifugation to recover the plasma, then dosage of the tryptase.

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Laura Polivka, MD · Assistance Publique - Hôpitaux de Paris

  • Luc de Chaisemartin, MD · Assistance Publique - Hôpitaux de Paris

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-21
Primary Completion
2022-10-24
Completion
2022-10-24

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05323188 on ClinicalTrials.gov