- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Lena-Luise Becker, Dr. med.
- 전화번호: 0049 30 450 566 112
- 이메일: lena-luise.becker@charite.de
연구 연락처 백업
- 이름: Angela M. Kaindl, Prof. Dr.
- 전화번호: 0049 30 450 566112
- 이메일: angela.kaindl@charite.de
연구 장소
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State of Berlin
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Berlin, State of Berlin, 독일, 13353
- 모병
- Charite- Universitatsmedizin Berlin
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연락하다:
- Lena-Luise Becker, Dr. med.
- 전화번호: 004903450566112
- 이메일: lena-luise.becker@charite.de
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- TNPO2 variant
Exclusion Criteria:
- no consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
intelligence quotient
기간: 10 years
|
Developmental Outcome using standardized testing (BAYLEY III or WISC-V)
|
10 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Psychiatric disorders
기간: 10 years
|
Number of patients with a psychiatric disorders
|
10 years
|
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Functional anaylsis of variants
기간: 2 years
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Number of gain-of-function variants in cohort
|
2 years
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- Target-TNPO2
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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