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临床试验/NCT07173842
NCT07173842尚未招募不适用

Establishment of the NeuroPsyBiT-BD Omics Program: Development of a Turkish Bipolar Disorder Biobank Integrating Genomic and Epigenomic Profiling With Structured Clinical Phenotyping and Secure Data Infrastructure

Selçuk State Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
试验地点
1
主要终点
Number of Participants with Successfully Collected and Biobanked DNA Samples

研究概览

简要总结

Brief Summary The goal of this observational study is to establish a comprehensive biobank and phenotypic data repository for patients diagnosed with bipolar disorder in Türkiye. The study will prospectively collect standardized clinical, demographic, lifestyle, and biological data to create a secure genomic and epigenomic research resource.

The main questions it aims to answer are:

Can large-scale, standardized phenotypic and biological data collection improve the understanding of bipolar disorder subtypes and disease course?

Can integration of biobank samples with genomic and epigenomic analyses identify biomarkers that inform future diagnosis, prognosis, and treatment strategies?

Participants will:

Provide consent and demographic/clinical information using the NeuroPsyBiT Data Collector software.

Contribute blood samples (e.g., EDTA tubes) for DNA extraction, genotyping, and future epigenomic studies.

Allow secure storage of their data and biospecimens in the RTSGD biobank for use in ethically approved research projects.

All data and samples will be collected and stored under strict ethical oversight and in compliance with national (KVKK) and international (GDPR) data protection regulations. Personally identifiable information will not be shared, and access to the biobank and dataset will only be granted after approval by institutional review boards and ethics committees.

This registry will create the foundation for future genome-wide association studies (GWAS) and epigenome-wide association studies (EWAS), supporting the long-term goal of developing precision psychiatry tools for bipolar disorder.

详细描述

This project, NeuroPsyBiT-BD-001: Genomic & Epigenomic Biobank of Bipolar Disorder, is an observational patient registry designed to establish a large-scale biobank and standardized phenotypic data platform for individuals with bipolar disorder in Türkiye.

Objectives and Rationale:

Bipolar disorder (BD) is a chronic and heterogeneous psychiatric condition with high morbidity, relapse rates, and unmet clinical needs. Genetic and epigenetic factors are believed to play a central role in its pathogenesis, yet reliable biomarkers remain scarce. By combining deeply phenotyped clinical data with biological samples, this registry seeks to create a robust foundation for genome-wide association studies (GWAS) and epigenome-wide association studies (EWAS). This approach will enable future biomarker discovery, stratification of subtypes, and exploration of treatment response predictors.

Study Design:

Population: Patients diagnosed with bipolar disorder according to DSM-5 criteria will be recruited through the NeuroPsyBiT consortium, a partnership between the Research and Treatment Society of Genetic Disorders (RTSGD) and the Department of Psychiatry at Selçuk University Medical Faculty.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Participants with Successfully Collected and Biobanked DNA Samples

时间窗: From enrollment to 24 months

Count of bipolar disorder participants whose blood samples (EDTA tubes) are successfully collected, processed, quality-checked (DNA yield/purity), and stored in the RTSGD-NeuroPsyBiT Biobank under ISO standards

次要结局

  • Completeness of Phenotypic Dataset per Participant(24 months)
  • Proportion of Biobanked Samples Ready for Genomic/Epigenomic Analysis(24 months)
  • Rate of Successful Data-Sample Linkage(24 months)

研究者

发起方
Selçuk State Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rukiye Tekdemir

Associate Professor Dr.

Selçuk State Hospital

研究点 (1)

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