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NCT05323188: KID-Tryp

Serum Basal Tryptase Levels in Healthy Children

Completed Last updated 12 September 2025
What this trial tests

trial testing Tryptase dosage in Basal Tryptasemia in 402 participants. Completed in 24 October 2022.

Timeline
21 April 2022
Primary endpoint
24 October 2022
24 October 2022

Quick facts

Lead sponsorAssistance Publique - Hôpitaux de Paris
StatusCompleted
Study typeOBSERVATIONAL
Enrollment402
Start date21 April 2022
Primary completion24 October 2022
Estimated completion24 October 2022
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Under 17, any sex, with Basal Tryptasemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

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Data sources for this page

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