Rare DisordersNCT01384305
Establish a "Taiwan Rare Disorder Tissue Bank", to Collect and Repost Biological Samples and Disease Information From Patients With Rare Disorders
An observational study of Rare Disorders, run by China Medical University Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rare Disorders
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with rare disorders.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Rare Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rare DisordersStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384305
- Sponsor's protocol ID
- DMR98-IRB-255-3
- Status last verified
- Jun 2011
- First submitted
- 28 Jun 2011
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establish a "Taiwan Rare Disorder Tissue Bank", to Collect and Repost Biological Samples and Disease Information From Patients With Rare Disorders
- ClinicalTrials.gov ID
- NCT01384305
- Acronym / sponsor ID
- DMR98-IRB-255-3
- Conditions
- Rare Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Dec 2009
- First posted
- 29 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with rare disorders.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rare Disorders, run by China Medical University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2011.