Endoscopic Ultrasonographic Staging and Conventional Endo... | NCT01832246

Studies
Endoscopic Ultrasonographic Staging and Conventional Endoscopic Staging for Depth of Invasion for Early Gastric Cancer

NCT01832246

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Nov 18, 2014Estimated

Enrollment

560Estimated

Phase

Not provided

Conditions

Gastric Tumor
Early Gastric Cancer

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

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jul 4, 2012

First Submission Date that Met QC Criteria

Apr 15, 2013

First Posted Date

Apr 16, 2013Estimated

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

Nov 17, 2014

Last Update Posted Date

Nov 18, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jeongmin Choi, professor, Department of Internal Medicine and Liver Research Institute, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

The accurate prediction of depth of tumor invasion in early gastric cancer is essential for the proper selection of candidates for endoscopic resection. Conventional endoscopy and endoscopic ultrasonography have been useful diagnostic method for depth of invasion in early gastric cancer. However, there has been no prospective comparative study on the accuracy between the 2 methods. Therefore, the investigators prospectively compare the accuracy between the 2 methods regarding prediction of depth of invasion.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

560Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diagnostic accuracy between endoscopic ultrasonographic staging and conventional endoscopic staging		up to 2.5 years (end of study, December 2014)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with early gastric adenocarcinoma undergo both endoscopic staging and endoscopic ultrasonographic staging for depth of invasion

Exclusion Criteria:

patients had previously received neoadjuvant chemotherapy or chemoradiotherapy
patients with obviously advanced gastric cancer by endoscopy
the evidence of distant metastasis or extensive adjacent organ invasion on abdominal CT scan

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients with early gastric adenocarcinoma is prospectively enrolled at Seoul National University Hospital.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jeongmin Choi, M.D.	Contact	82-2-2072-7209		doct00@hanmail.net

Overall Officials

Name	Affiliation	Role
Sang Gyun Kim, M.D.	Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine	Study Director
Jeongmin Choi, M.D.	Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Gastroenterology, Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital		Seoul	Seoul	110-744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided