Control ConditionDOSHOMASSNCT06694415
Determining Paediatric Usual Values for Hormones Dosages by LC-MS/MS
An observational study of Control Condition, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Liquid chromatography coupled with mass spectrometry (LC-MS/MS) is now the method of choice for steroid hormone analysis, as it enables analyses to be carried out on small-volume samples on a wider range of hormones, with improved specificity compared with immunoassays. Read more about this study
- Who is it for?
- Ages Up to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Control Condition
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients followed in paediatrics from birth to 20 years undergoing a blood sample as part of their pathology routine follow-up in one of the identified recruiting centers (see below). Patients with no identified or suspected endocrine pathology or no infectious or inflammatory disorder.
Who may be able to join
- Male or female patient ≤ 20 years old
- undergoing a blood sample as part of their pathology routine follow-up
Who cannot join
- Any identified or suspected endocrine pathology
- Any acute infectious or inflammatory disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'Endocrinologie Pédiatrique-Explorations Fonctionnelles Hôpital Trousseau
Paris, Paris, 75012
Eloïse Giabicani, MD, PhD, +33 (0)1 49 28 66 94, eloise.giabicani@aphp.fr
Marie-Pierre Luton, PhD, +33(0) 1 87 89 26 00, mariepierre.luton@aphp.fr
About this study
Official title: Determining Paediatric Usual Values for Hormones Dosages by Mass Spectrometry
Liquid chromatography coupled with mass spectrometry (LC-MS/MS) is now the method of choice for steroid hormone analysis, as it enables analyses to be carried out on small-volume samples on a wider range of hormones, with improved specificity compared with immunoassays. Hormone assays currently face a twofold problem: on the one hand, immunoassays are highly dependent on the synthesis of antibody kits manufactured by companies with immunotechnology expertise; on the other hand, these immunoassays may require the use of radioactive products for quantification, generating considerable risks for both staff and environment. There are international recommendations from expert societies (World Anti-Doping Agency, Endocrine society) to develop new, more reliable assay methods, such as LC-MS/MS, and to phase out immuno- and radioassay techniques.
However, changing measurement methods requires the development of reference values to maintain and optimize the management of patients.
The aim of this project is therefore to establish usual values in a paediatric population, through collaboration between the clinical departments of the APHP and the METOMICS laboratory, which has mastered the technology.
Read the detailed description
This is a prospective, multicentric, non-randomized. The study will be uncontrolled, as it will use subjects considered "healthy" to establish reference values.
Recruitment is planned to take place in hospital consultations at recruiting centers belonging to the AP-HP.
During the blood sample prescribed as part of the follow-up consultation, an additional blood tube will be collected after information, consent and inclusion.
The following acts and procedures will be added as part of the research:
- additional tube, respecting the total volume taken according to weight (maximum volume of 2.7mL);
- Routine circuit for sending and receiving the tube to ensure the relevance of standards established in real life.
- A biological collection will be set up. Pseudonymized data will be collected on a secure REDCap database. The source data will be: Recruiting center; Age; Gender; Pubertal stage if available; Results of blood tests carried out by mass spectrometry as part of this research.
The clinical database will be completed by investigators from the Endocrine Functional Explorations Department at Trousseau Hospital and biologists from the METOMICS Department at Saint-Antoine Hospital. Data will not be processed outside the AP-HP. Data will be kept in an active secured database for the duration of the study and up to 2 years after the last publication, and archived for 15 years.
Mass spectrometry analyses will be carried out under the supervision of Pr Antonin Lamazière, Head of the Clinical Metabolomics Department at Hôpital Saint Antoine. Data from these analyses will be stored in the same clinical laboratory and shared only with/between the principal investigator and the study methodologist.
During the research phase, the collection will be stored at the Clinical Metabolomics Department (METOMICS) laboratory, under the responsibility of Prof. Antonin Lamazière, for 2 years. At the end of the research, the samples will be stored for a maximum of 15 years.
- Conditions
- Control Condition
- Keywords
- LC-MS/MS, Hormones, Children, Usual values
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control individuals below 20 years of age | blood sample with hormone dosages |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine paediatric usual values for hormones dosages by mass spectrometry
internal quality control (IQC) suitability/match between the one provided by the manufacturer or developed in-house, and inter-laboratory comparisons (EQA/EIL)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start2 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Control ConditionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eloïse Giabicani, MD, PhD, Principal investigator, Organizational Affiliation: Assistance Publique - Hôpitaux de Paris (AP-HP en général)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694415
- Sponsor's protocol ID
- APHP240887
- Other IDs
- IDRCB-2024-A01634-43
- Acronym
- DOSHOMASS
- Status last verified
- Aug 2025
- First submitted
- 15 Nov 2024
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Paediatric Usual Values for Hormones Dosages by Mass Spectrometry
- ClinicalTrials.gov ID
- NCT06694415
- Acronym / sponsor ID
- DOSHOMASS / APHP240887
- Conditions
- Control Condition
- Keywords
- LC-MS/MS, Hormones, Children, Usual values
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Nov 2024 (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.
Liquid chromatography coupled with mass spectrometry (LC-MS/MS) is now the method of choice for steroid hormone analysis, as it enables analyses to be carried out on small-volume samples on a wider range of hormones, with improved specificity compared with immunoassays. Hormone assays currently face a twofold problem: on the one hand, immunoassays are highly dependent on the synthesis of antibody kits manufactured by companies with immunotechnology expertise; on the other hand, these immunoassays may require the use of radioactive products for quantification, generating considerable risks for both staff and environment. There are international recommendations from expert societies (World Anti-Doping Agency, Endocrine society) to develop new, more reliable assay methods, such as LC-MS/MS, and to phase out immuno- and radioassay techniques.
However, changing measurement methods requires the development of reference values to maintain and optimize the management of patients.
The aim of this project is therefore to establish usual values in a paediatric population, through collaboration between the clinical departments of the APHP and the METOMICS laboratory, which has mastered the technology.
Detailed description
This is a prospective, multicentric, non-randomized. The study will be uncontrolled, as it will use subjects considered "healthy" to establish reference values.
Recruitment is planned to take place in hospital consultations at recruiting centers belonging to the AP-HP.
During the blood sample prescribed as part of the follow-up consultation, an additional blood tube will be collected after information, consent and inclusion.
The following acts and procedures will be added as part of the research:
- additional tube, respecting the total volume taken according to weight (maximum volume of 2.7mL);
- Routine circuit for sending and receiving the tube to ensure the relevance of standards established in real life.
- A biological collection will be set up. Pseudonymized data will be collected on a secure REDCap database. The source data will be: Recruiting center; Age; Gender; Pubertal stage if available; Results of blood tests carried out by mass spectrometry as part of this research.
The clinical database will be completed by investigators from the Endocrine Functional Explorations Department at Trousseau Hospital and biologists from the METOMICS Department at Saint-Antoine Hospital. Data will not be processed outside the AP-HP. Data will be kept in an active secured database for the duration of the study and up to 2 years after the last publication, and archived for 15 years.
Mass spectrometry analyses will be carried out under the supervision of Pr Antonin Lamazière, Head of the Clinical Metabolomics Department at Hôpital Saint Antoine. Data from these analyses will be stored in the same clinical laboratory and shared only with/between the principal investigator and the study methodologist.
During the research phase, the collection will be stored at the Clinical Metabolomics Department (METOMICS) laboratory, under the responsibility of Prof. Antonin Lamazière, for 2 years. At the end of the research, the samples will be stored for a maximum of 15 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control individuals below 20 years of age | – | –blood sample with hormone dosages |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients followed in paediatrics from birth to 20 years undergoing a blood sample as part of their pathology routine follow-up in one of the identified recruiting centers (see below). Patients with no identified or suspected endocrine pathology or no infectious or inflammatory disorder.
Key inclusion criteria (2 listed)
- Male or female patient ≤ 20 years old
- undergoing a blood sample as part of their pathology routine follow-up
Key exclusion criteria (2 listed)
- Any identified or suspected endocrine pathology
- Any acute infectious or inflammatory disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
to determine paediatric usual values for hormones dosages by mass spectrometry
Time frame: 1 week
internal quality control (IQC) suitability/match between the one provided by the manufacturer or developed in-house, and inter-laboratory comparisons (EQA/EIL)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Eloïse Giabicani, MD, PhD principal investigator
Organizational Affiliation: Assistance Publique - Hôpitaux de Paris (AP-HP en général)
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 Control Condition, 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 26 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eloïse Giabicani, MD, PhD (+33 (0)1 49 28 66 94, eloise.giabicani@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to determine paediatric usual values for hormones dosages by mass spectrometry (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2025.