임상연구정보서비스

Search: Search

Gastric low grade adenoma, follow up or endoscopic submucosal dissection?: A pilot multicenter study

Status Approved

First Submitted Date

2017/04/06
Registered Date

2017/04/19
Last Updated Date

2017/04/17

Move list page

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002314
Unique Protocol ID	2011-1039
Public/Brief Title	Gastric adenoma: Follow up or ESD?
Scientific Title	Gastric low grade adenoma, follow up or endoscopic submucosal dissection?: A pilot multicenter study
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2011-1039
Approval Date	2011-06-30
Institutional Review Board Name	Hallym University Sacred Heart Hospital IRB
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Il Hyun Baek
Title	Prof
Telephone	+82-42-611-3053
Affiliation	Eulji University Hospital
Address	1306, Dunsan-dong, Seo-gu, Daejeon,
Contact Person for Public Queries
Name	Il Hyun Baek
Title	Prof
Telephone	+82-42-611-3053
Affiliation	Eulji University Hospital
Address	1306, Dunsan-dong, Seo-gu, Daejeon,
Contact Person for Updating Information
Name	Il Hyun Baek
Title	Prof
Telephone	+82-42-611-3053
Affiliation	Eulji University Hospital
Address	1306, Dunsan-dong, Seo-gu, Daejeon,

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 3
Overall Recruitment Status	Active, not recruiting
Date of First Enrollment	2011-06-30 Actual
Target Number of Participant	250
Primary Completion Date
Study Completion Date
Name of Study	Hallym University Medical Center
Recruitment Status	Active, not recruiting
Date of First Enrollment	2011-06-30 ,
Recruitment Status by Participating Study Site 2
Name of Study	Hallym University Medical Center-Kangnam
Recruitment Status	Active, not recruiting
Date of First Enrollment	2011-06-30 ,
Recruitment Status by Participating Study Site 3
Name of Study	Chung-Ang University
Recruitment Status	Active, not recruiting
Date of First Enrollment	2011-06-30 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Eulji University Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Eulji University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	p53 mutation is the most common genetic alteration in cancers and influences clinical progression. Ki-67 protein is a cellular marker for proliferation in cancer or premalignant lesion. We investigated whether there was any difference in the expression of p53 and Ki-67 in gastric adenoma (GA) and gastric cancer (GC).

Study Summary Information

Lay Summary

p53 mutation is the most common genetic alteration in cancers and influences clinical progression. Ki-67 protein is a cellular marker for proliferation in cancer or premalignant lesion. We investigated whether there was any difference in the expression of p53 and Ki-67 in gastric adenoma (GA) and gastric cancer (GC).

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Cohort
Time Perspective	Retrospective
Target Number of Participant	250
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label gastric tumor
Cohort/ Group 1	Cohort/Group Description Treatment decission according to Immunohistochemical staining using monoclonal antibodies to p53 and Ki-67 (p53 and Ki-67 positivity according to adenoma and cancer)
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Patients visited university hospital at Seoul and Daejeon
Sampling Method	Non-probabilistic extraction according to medical records review
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (D13.1)Benign neoplasm of stomach
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~90Year
	Description patients agreed to procedure
Exclusion Criteria	patients refused to consents
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	mean tumor sizes
Timepoint	Medical records review
Secondary Outcome(s) 1
Outcome	p53 positivity
Timepoint	Medical records review

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

Move list page Move to top