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NCT05323188: KID-Tryp
Serum Basal Tryptase Levels in Healthy Children
trial testing Tryptase dosage in Basal Tryptasemia in 402 participants. Completed in 24 October 2022.
24 October 2022
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 402 |
| Start date | 21 April 2022 |
| Primary completion | 24 October 2022 |
| Estimated completion | 24 October 2022 |
| Sites | 1 location across France |
Drugs / interventions tested
- Tryptase dosage
Conditions studied
- Basal Tryptasemia — all drugs for Basal Tryptasemia →
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.
Verify or expand the search:
- PubMed search for NCT05323188
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05323188 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 12 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05323188.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing