Proteomics Study by Serum and Platelet With Neurodegenera... | NCT01564316

Studies
Proteomics Study by Serum and Platelet With Neurodegeneration Disease Patients

NCT01564316

Sponsor

Seoul National University Hospital

Status

Terminated

Last Update Posted

Apr 15, 2016Estimated

Enrollment

22Actual

Phase

Not provided

Conditions

Biomarker With Neurodegeneration Patients

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study has been terminated due to difficulties in gathering the patient samples.

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Mar 11, 2012

First Submission Date that Met QC Criteria

Mar 23, 2012

First Posted Date

Mar 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2016

Last Update Posted Date

Apr 15, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
neurodegeneration patients		•neurodegeneration patients and control group include dementia patients visited the part of neurology

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

exclusion criteria:

under eighteen years of age
when participants cannot understand subject of this study
cannot accept this study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

neurodegeneration patients group include dementia patients visited the part of neurology.

(almost after diagnosis)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manho Kim, Professor	Seoul National University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, Seoul National University Hospital		Seoul	Seoul	110744	South Korea