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Blood test norms for kids could end diagnostic delays

NCT ID NCT05323188

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This completed study measured normal tryptase levels in 402 children aged 0-18 to help doctors better diagnose mast cell disorders like mastocytosis and MCAS. Researchers used leftover blood from routine tests in children undergoing surgery. Knowing these normal ranges could reduce years of misdiagnosis and improve care for affected children.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors diagnose mast cell disorders in children more accurately and quickly using a simple blood test.
What could go wrong
This is an observational study that only establishes normal ranges, not a treatment trial. It may not directly improve patient outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

402 people

The number who actually took part.

Started

Apr 2022

Finished

Oct 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients 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, in order to have a control pediatric population with no excess of chronic inflammatory or allergic disease compared to the general French population.

Ages

Up to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hereditary alpha tryptasemia syndrome mast cell activation syndrome mastocytosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Basal tryptasemia

Contacts and locations

Locations

  • Hôpital Necker-Enfants Malades

    Paris, 75015, France