- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Lena-Luise Becker, Dr. med.
- Telefonnummer: 0049 30 450 566 112
- E-post: lena-luise.becker@charite.de
Studera Kontakt Backup
- Namn: Angela M. Kaindl, Prof. Dr.
- Telefonnummer: 0049 30 450 566112
- E-post: angela.kaindl@charite.de
Studieorter
-
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State of Berlin
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Berlin, State of Berlin, Tyskland, 13353
- Rekrytering
- Charite- Universitatsmedizin Berlin
-
Kontakt:
- Lena-Luise Becker, Dr. med.
- Telefonnummer: 004903450566112
- E-post: lena-luise.becker@charite.de
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- TNPO2 variant
Exclusion Criteria:
- no consent
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
intelligence quotient
Tidsram: 10 years
|
Developmental Outcome using standardized testing (BAYLEY III or WISC-V)
|
10 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Psychiatric disorders
Tidsram: 10 years
|
Number of patients with a psychiatric disorders
|
10 years
|
|
Functional anaylsis of variants
Tidsram: 2 years
|
Number of gain-of-function variants in cohort
|
2 years
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- Target-TNPO2
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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