- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07699510
Exspanding the Knowledge About TNPO2-Associated Disorders (Target-TNPO2)
Development of New Therapeutic Approaches for TNPO2-Associated Disorders
The Target-TNPO2 is an international, multicenter observational registry designed to collect comprehensive clinical, genetic, neurodevelopmental, and longitudinal data from individuals with pathogenic or likely pathogenic variants in the TNPO2 gene.
This aids to improve the knowledge and clinical progression on TNPO2-associated disorders.
The investigators further aim to provide new insides into the pathomechanism of TNPO2 variants using blood samples.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Transportin-2 (TNPO2) encodes a member of the importin-β family of nuclear transport receptors, which mediate the selective transport of proteins containing nuclear localization signals from the cytoplasm into the nucleus. Nucleocytoplasmic transport is essential for numerous cellular processes, including gene regulation, RNA metabolism, cell differentiation, and neuronal development. Proper nuclear import is particularly critical during embryonic brain development, where tightly regulated trafficking of transcription factors and RNA-binding proteins is required for normal neurodevelopment.
Pathogenic germline variants in TNPO2 have recently been identified as the cause of a rare neurodevelopmental disorder. Reported individuals commonly present with global developmental delay, intellectual disability, hypotonia, delayed motor and language development, epilepsy in a subset of patients, and variable behavioral abnormalities, including features of autism spectrum disorder and schizophrenia. Additional manifestations, such as movement disorders, feeding difficulties, and dysmorphic features, have been described in some individuals. However, the phenotypic spectrum, disease mechanisms, and long-term clinical course remain incompletely understood due to the limited number of reported cases.
As additional patients are identified through genome and exome sequencing, the spectrum of TNPO2-associated disorders is expected to expand. Systematic collection of standardized clinical and molecular data is therefore essential to improve understanding of disease pathogenesis, define genotype-phenotype correlations, and establish evidence-based recommendations for clinical care.
Purpose of the Registry The TNPO2- Registry is an international, multicenter observational registry designed to collect comprehensive clinical, genetic, neurodevelopmental, and longitudinal data from individuals with pathogenic or likely pathogenic variants in the TNPO2 gene, as well as selected individuals with variants of uncertain significance supported by compatible clinical phenotypes.
The registry aims to create a centralized resource that facilitates collaboration among clinicians, researchers, and patient organizations while advancing knowledge of the natural history, clinical variability, and molecular basis of TNPO2-associated disorders.
Aditionally this study aims to characterize the variants and identify the underlying pathomachanism that is causative for the disorder using PBMCs from patients. These findings aim to test multiple FDA approved drugs to identify novel treatment options.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Lena-Luise Becker, Dr. med.
- Numéro de téléphone: 0049 30 450 566 112
- E-mail: lena-luise.becker@charite.de
Sauvegarde des contacts de l'étude
- Nom: Angela M. Kaindl, Prof. Dr.
- Numéro de téléphone: 0049 30 450 566112
- E-mail: angela.kaindl@charite.de
Lieux d'étude
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State of Berlin
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Berlin, State of Berlin, Allemagne, 13353
- Recrutement
- Charite- Universitatsmedizin Berlin
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Contact:
- Lena-Luise Becker, Dr. med.
- Numéro de téléphone: 004903450566112
- E-mail: lena-luise.becker@charite.de
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- TNPO2 variant
Exclusion Criteria:
- no consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
intelligence quotient
Délai: 10 years
|
Developmental Outcome using standardized testing (BAYLEY III or WISC-V)
|
10 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Psychiatric disorders
Délai: 10 years
|
Number of patients with a psychiatric disorders
|
10 years
|
|
Functional anaylsis of variants
Délai: 2 years
|
Number of gain-of-function variants in cohort
|
2 years
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- Target-TNPO2
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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