Biomarker With Neurodegeneration PatientsNCT01564316
Proteomics Study by Serum and Platelet With Neurodegeneration Disease Patients
An observational study of Biomarker With Neurodegeneration Patients, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Using to method of Proteomics, for aims to conquer intractable disease, try to access variety experiment. Biomarker is necessary to develop new diagnosis method and target of treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Biomarker With Neurodegeneration Patients
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2005to Jan 2014
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: neurodegeneration patients group include dementia patients visited the part of neurology. (almost after diagnosis)
Who may be able to join
- neurodegeneration patients and control group include dementia patients visited the part of neurology.
- over the age of 18
- when participants can understand subject of this study
- Total point of Mini Mental state exam(MMSE)should be Under 26 include MCI (mild cognitive impairment) and over GDS score 3points.
Who cannot join
- under eighteen years of age
- when participants cannot understand subject of this study
- cannot accept this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Neurology, Seoul National University Hospital
Seoul, Seoul, 110744
About this study
Using to method of Proteomics, for aims to conquer intractable disease, try to access variety experiment. Biomarker is necessary to develop new diagnosis method and target of treatment.
Read the detailed description
Following Seoul National University Hospital Institutional Review Board approval, obtain serum and platelet with neurodegeneration patients and control group visited the part of neurology, there'll be analysis to differentiate each other diseases use to method Proteomics. Biomarker will be screening via 1D/2D analysis, Mass analysis, database searching- the MASCOT search tool, SWISS-PROT and etc.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| neurodegeneration patients | •neurodegeneration patients and control group include dementia patients visited the part of neurology |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startMay 2005
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: The study has been terminated due to difficulties in gathering the patient samples.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biomarker With Neurodegeneration PatientsStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manho Kim, Professor, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564316
- Sponsor's protocol ID
- H-0505-148-016
- Status last verified
- Mar 2016
- First submitted
- 11 Mar 2012
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomics Study by Serum and Platelet With Neurodegeneration Disease Patients
- ClinicalTrials.gov ID
- NCT01564316
- Acronym / sponsor ID
- H-0505-148-016
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study has been terminated due to difficulties in gathering the patient samples.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Mar 2012 (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.
Using to method of Proteomics, for aims to conquer intractable disease, try to access variety experiment. Biomarker is necessary to develop new diagnosis method and target of treatment.
Detailed description
Following Seoul National University Hospital Institutional Review Board approval, obtain serum and platelet with neurodegeneration patients and control group visited the part of neurology, there'll be analysis to differentiate each other diseases use to method Proteomics. Biomarker will be screening via 1D/2D analysis, Mass analysis, database searching- the MASCOT search tool, SWISS-PROT and etc.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neurodegeneration patients | – | –•neurodegeneration patients and control group include dementia patients visited the part of neurology |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- neurodegeneration patients group include dementia patients visited the part of neurology. (almost after diagnosis)
Key inclusion criteria (4 listed)
- neurodegeneration patients and control group include dementia patients visited the part of neurology.
- over the age of 18
- when participants can understand subject of this study
- Total point of Mini Mental state exam(MMSE)should be Under 26 include MCI (mild cognitive impairment) and over GDS score 3points.
Key exclusion criteria (3 listed)
- under eighteen years of age
- when participants cannot understand subject of this study
- cannot accept this study
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
The study was stopped early (reason given: The study has been terminated due to difficulties in gathering the patient samples.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
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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.
Manho Kim, Professor study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biomarker With Neurodegeneration Patients, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: The study has been terminated due to difficulties in gathering the patient samples.). 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 15 Apr 2016.