NCT01451034

Brief Summary

Endoscopically, WHYX cancers demonstrated a vague extent of tumor spread due to pale color changes in both the background atrophic and metaplastic gastric mucosa. However, the clinical outcomes of WHYX cancers after endoscopic resection are unknown. The aim of this study was to evaluate clinical outcomes of WHYX cancers after endoscopic resection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
872

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 13, 2011

Completed
Last Updated

October 13, 2011

Status Verified

October 1, 2011

Enrollment Period

1.9 years

First QC Date

September 28, 2011

Last Update Submit

October 12, 2011

Conditions

WHYX LesionExtremely Well Differentiated Intestinal-type Adenocarcinoma

Keywords

WHYX lesionendoscopic resectioncomplete resectioncomplete resection rateendoscopic featureAverage size discrepancy

Outcome Measures

Primary Outcomes (1)

  • complete resection rate

    Complete resection was defined to have all of the following features: 1. grossly en bloc resection, 2. Tumor-free lateral and vertical resection margins, 3. No lymphovascular invasion, and 5. A depth of submucosal tumor invasion of less than 500 micrometers.

    6 months after endoscopical resection

Study Arms (2)

WHYX cancer group

ACTIVE COMPARATOR

WHYX cancer diagnosed by pathologic report

Procedure: WHYX cancer group

non-WHYX cancer group

PLACEBO COMPARATOR

all cancer except WHYX cancer diagnosed by pathologic report

Procedure: WHYX cancer group

Interventions

WHYX cancer groupPROCEDURE

WHYX cancer diagnosed by pathologic report

WHYX cancer groupnon-WHYX cancer group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • From January 2009 to December 2010 enrolled 872 patients with EGC

You may not qualify if:

  • EGC with regional lymph node metastasis in radiologic finding endoscopically suspicious submucosal invasion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2011

First Posted

October 13, 2011

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 13, 2011

Record last verified: 2011-10

Locations

KR(1)