- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01384305
Establish a "Taiwan Rare Disorder Tissue Bank", to Collect and Repost Biological Samples and Disease Information From Patients With Rare Disorders
June 28, 2011 updated by: China Medical University Hospital
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.
Study Overview
Status
Unknown
Conditions
Detailed Description
Investigation Plan
- Study Period:From 2009 to 2013
- Study Population:Patients with rare disorders.
- Planned Number of Subjects: 300~500 Subjects will be included in CMU.
- 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.
- 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.
- Study Site: Mainly in OPD that related to rare disorders.
- Study Materials:Blood (for plasma, DNA and cell line), a questionnaire and a chart review form. Tissue samples are acceptable as well.
- 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.
Study Type
Observational
Enrollment (Anticipated)
500
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with rare disorders.
Description
Inclusion 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.
Exclusion 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Retrospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Study Registration Dates
First Submitted
June 28, 2011
First Submitted That Met QC Criteria
June 28, 2011
First Posted (Estimate)
June 29, 2011
Study Record Updates
Last Update Posted (Estimate)
June 29, 2011
Last Update Submitted That Met QC Criteria
June 28, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMR98-IRB-255-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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