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Clinical Trials in France / NCT06138509
Recruiting Observational

Peripheral Serotonin and Albinism

NCT06138509 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2024-02-06
Last updated
2025-09-12

Condition(s) studied

Oculocutaneous Albinism

Investigational drug(s) / intervention(s)

Dosage of serotonin and metabolitesBlood parameters

Dosage of serotonin and metabolites: The dosages of serotonin and its metabolites will be performed by the INSERM U1016 unit at Cochin Institute.

Blood parameters: The characterization of blood parameters : complete blood count (CBC), reticulocytes, C-reactive protein (CRP), iron studies (ferritin, serum iron, transferrin and transferrin saturation), hemoglobin electrophoresis, erythropoietin, will be added using standard methods at the Necker hematology laboratory if not carried out as part of the routine care.

Study summary

Serotonin (5-HT or 5-hydroxytryptamine) is a monoamine primarily known for its role as a neurotransmitter in the central nervous system (CNS). However, the functions of serotonin go beyond its role in the central nervous system: different peripheral tissues have the capacity to produce and/or use serotonin locally, forming systems called "micro-serotonergic" systems. Among the peripheral roles of serotonin, previous work by the Iron and Immunity team, INSERM U1016, Institut Cochin (Paris), was able to show that serotonin has a positive role on erythropoiesis and the survival of red blood cells, and the team's ongoing work suggests that serotonin also impacts iron metabolism.

In humans and in mouse models, several studies have suggested a role for serotonin in pigmentation. In certain syndromic forms of albinism such as Hermansky Pudlak syndrome, platelet serotonin levels are reduced in connection with a decrease in dense platelet granules (delta granules): this characteristic is even part of the diagnostic criteria.

Preliminary data from the Iron and Immunity team found:

* Changes in serotonin levels in children with albinism compared to control patients,
* Changes in hemoglobin level and mean corpuscular volume (MCV) in children with albinism (towards anemia and microcytosis),
* Changes in the iron balance in children with albinism (towards iron deficiency).

The hypothesis of this research is that peripheral serotonin plays a role in the clinical and biological manifestations of oculocutaneous albinism.

Eligibility

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: Patients: * Patients with albinism aged 2 to 17 years * Followed in the MAGEC-Necker reference center (reference center for rare diseases of the skin and mucous membranes of genetic origin), during the inclusion period * Information of parental authority holders of patients and patients of understanding age, and collection of consent from parental authority holders and patients. Controls: * Patients aged 2 to 17 years old * Having consulted in Necker hospital during the inclusion period in the emergency and surgical services and whose care required a blood test analyzed in the hematology laboratory of the Necker hospital. * Normal complete blood count (CBC) * Normal C-reactive protein test (CRP) * Absence of opposition from parental authority holders within one month of after sending the study information note. Exclusion Criteria: Patients: \- Inability to have a blood test Controls: * Abnormal blood count * Elevation of CRP above laboratory standard

Primary outcome measure(s)

  • Level of serotonin and its metabolites in serum — Day 0
    Levels of serotonin and its metabolites in serum in children with albinism, compared with control children.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Necker-Enfants Malades Paris France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06138509 on ClinicalTrials.gov ↗ ← All trials in France