Basal TryptasemiaKID-TrypNCT05323188
Serum Basal Tryptase Levels in Healthy Children
An observational study of Basal Tryptasemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Basal Tryptasemia
- What is being tested?
- Tryptase dosage
- How many people
- 402 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2022to 24 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Patients hospitalized in departments other than surgery at Necker-Enfants Malades Hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Basal Tryptasemia According to Age in a Pediatric Control Population
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.
Read more
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.
Read the detailed 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.
At CEREMAST, for the pediatric branch, just over 700 children with mastocytosis and 150 with MCAS are followed. For each patient, a tryptase assay is performed. Over the years, CEREMAST is able to confirm that the standard of tryptase currently given as <11.4µg/L is not valid in children and clearly objectify that the level of normal tryptase increases with age in the child. Several patients with MCAS with hereditary hyper-alpha-tryptasemia (HAT) are followed at CEREMAST with diagnostic delays of 4 years on average. The knowledge among the doctors who took care of these patients that a tryptase at 7µg/L can be pathological in children could have avoided this wandering, and allowed the faster implementation of an effective antihistamine treatment.
Recent studies have shown that familial hypertryptasemia or hereditary hyper-alpha-tryptasemia (HAT) of autosomal dominant transmission was associated with an increase in the number of copies of the TPSAB1 gene, coding for tryptase alpha 1 and beta. By now systematically looking for amplifications of the TPSAB1 gene in all CEREMAST patients, it has been noted that a duplication may be associated with a tryptase at 6 μg/L, considered normal in children.
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 MCASs and mastocytosis.
- Conditions
- Basal Tryptasemia
- Being tested
- Tryptase dosage
- Keywords
- Serum basal tryptase levels, Pediatric control population, Basal tryptasemia according to age, Basal tryptasemia according to sex, Mastocytosis, Mast cell activation syndromes (MCAS)
- Medical subject headings
- Mastocytosis, Mast Cell Activation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tryptase dosageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Control pediatric population: no excess of chronic inflammatory or allergic disease compared to the general French population. Receives: Other: Tryptase dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum basal tryptase levels according to age
Basal tryptasemia according to age in a pediatric control population.
Measured: 8 months
Secondary outcomes (1)
Serum basal tryptasemia levels according to sex
Basal tryptasemia according to sex in a pediatric control population.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start21 Apr 2022
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Basal TryptasemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Laura Polivka, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisLuc de Chaisemartin, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323188
- Sponsor's protocol ID
- APHP220353
- Acronym
- KID-Tryp
- Status last verified
- Sep 2025
- First submitted
- 4 Apr 2022
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Puel 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.
PubMed 39425617
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Basal Tryptasemia According to Age in a Pediatric Control Population
- ClinicalTrials.gov ID
- NCT05323188
- Acronym / sponsor ID
- KID-Tryp / APHP220353
- Conditions
- Basal Tryptasemia
- Keywords
- Serum basal tryptase levels, Pediatric control population, Basal tryptasemia according to age, Basal tryptasemia according to sex, Mastocytosis, Mast cell activation syndromes (MCAS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
At CEREMAST, for the pediatric branch, just over 700 children with mastocytosis and 150 with MCAS are followed. For each patient, a tryptase assay is performed. Over the years, CEREMAST is able to confirm that the standard of tryptase currently given as <11.4µg/L is not valid in children and clearly objectify that the level of normal tryptase increases with age in the child. Several patients with MCAS with hereditary hyper-alpha-tryptasemia (HAT) are followed at CEREMAST with diagnostic delays of 4 years on average. The knowledge among the doctors who took care of these patients that a tryptase at 7µg/L can be pathological in children could have avoided this wandering, and allowed the faster implementation of an effective antihistamine treatment.
Recent studies have shown that familial hypertryptasemia or hereditary hyper-alpha-tryptasemia (HAT) of autosomal dominant transmission was associated with an increase in the number of copies of the TPSAB1 gene, coding for tryptase alpha 1 and beta. By now systematically looking for amplifications of the TPSAB1 gene in all CEREMAST patients, it has been noted that a duplication may be associated with a tryptase at 6 μg/L, considered normal in children.
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 MCASs and mastocytosis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | – | Other: Tryptase dosageControl pediatric population: no excess of chronic inflammatory or allergic disease compared to the general French population. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients hospitalized in departments other than surgery at Necker-Enfants Malades Hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tryptase dosageCollection of biological waste from a blood test for complete blood count (CBC) of care. Centrifugation to recover the plasma, then dosage of the tryptase. | Other | Subjects |
Primary outcome
Serum basal tryptase levels according to age
Time frame: 8 months
Basal tryptasemia according to age in a pediatric control population.
1 secondary outcome
Serum basal tryptasemia levels according to sex
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publication: PubMed 39425617Puel 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.
- Individual participant dataSharing planned: No
Related trials for Basal Tryptasemia
Active, not recruiting
Investigation of the Frequency of Hereditary Hyper Alpha-tryptasemia in Patients With Elevated Basal Tryptasemia
Allergic Bronchiolitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Polivka, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Luc de Chaisemartin, MD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Tryptasemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum basal tryptase levels according to age (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05323188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.