跳至主要内容
临床试验/NCT01384305
NCT01384305Unknown不适用

Establish a "Taiwan Rare Disorder Tissue Bank", to Collect and Repost Biological Samples and Disease Information From Patients With Rare Disorders

China Medical University Hospital0 个研究点目标入组 500 人开始时间: 2009年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
500

研究概览

简要总结

Even though rare disorders usually have limited case numbers, they have induced huge impacts on patients and their families, and has heavily burdened on our society and healthcare system as well. Therefore, it is essential to detect the occurrence of disorders and thus take appropriate measures as early as possible. The preventive goal is based on comprehensive understanding on rare disorders, available diagnostic and therapeutic approaches. However, studies related to rare disorders are often impeded by limited sample sizes and infrequent exchange of research materials among institutes. After referring to foreign experiences, the investigators have noticed that a non-profit tissue bank which can reposit biological samples and thus provide researchers access to samples, may be a solution. Through sharing this public asset, the investigators believe not only quantity and quality of rare disorder studies will be improved, the collaboration between various research institutes can also be strengthened afterwards. Most important of all, those achievements can ultimately benefit patients, families and the whole society.

详细描述

Investigation Plan

  1. Study Period:From 2009 to 2013
  2. Study Population:Patients with rare disorders.
  3. Planned Number of Subjects: 300~500 Subjects will be included in CMU.
  4. Inclusive Criteria:A patient who is clinically diagnosed as one of rare disorders notified by Department of Health or our organization. Or a patient who is diagnosed as a probable rare disorder case by physicians.
  5. Exclusive Criteria:Patients whose physical or mental status is not suitable by the judgment of health professionals. Or a patient who is <20 years old or interdictory, yet without getting the permission from his/her legal representatives.
  6. Study Site: Mainly in OPD that related to rare disorders.
  7. Study Materials:Blood (for plasma, DNA and cell line), a questionnaire and a chart review form. Tissue samples are acceptable as well.
  8. Application of collected materials:Samples and information will be restored in appropriate manner, and researchers will be encouraged to apply them for biological studies in the field of rare disorders thereafter.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • A patient who is clinically diagnosed as one of rare disorders notified by Department of Health or our organization. Or a patient who is diagnosed as a probable rare disorder case by physicians.

排除标准

  • Patients whose physical or mental status is not suitable by the judgment of health professionals. Or a patient who is < 20 years old or interdictory, yet without getting the permission from his/her legal representatives.

研究者

申办方类型
Other

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