Follow-up of the Natural Course of the Small EUS-suspecte... | NCT01084460

Studies
Follow-up of the Natural Course of the Small EUS-suspected Gastric Gastointestinal Stromal Tumors

NCT01084460

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Mar 10, 2010Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Tumor

Interventions

Not provided

Countries

Not provided

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 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1997

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Mar 8, 2010

First Submission Date that Met QC Criteria

Mar 9, 2010

First Posted Date

Mar 10, 2010Estimated

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

Mar 9, 2010

Last Update Posted Date

Mar 10, 2010Estimated

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

Gastric gastrointestinal stromal tumors (GISTs) less than 2 cm are usually followed up conservatively. However, little is known about the natural course of small GISTs. The goal of this study was to evaluate the clinical course of the small EUS-suspected gastric GISTs and to determine the size predicting subsequent progression with increased malignant potential.

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

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EUS-suspected gastric GISTs		In this retrospective study, 50 patients with EUS-suspected gastric GISTs, less than 3 cm were enrolled and had EUS follow-up at least two times over a period of more than 24 months.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(1) a small tumor size, less than 3 cm;
(2) patients declined surgical intervention at initial identification of the lesion;
(3) at least two EUS follow-up procedures were recorded;
(4) the EUS follow-up period was more than 24 months.

Exclusion Criteria:

(1) a tumor size, larger than 3 cm;
(2) less two EUS follow-up procedures were recorded;
(3) the EUS follow-up period was less 24 months.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

This was a retrospective study. We reviewed 256 consecutive patients with the diagnosis of suspected gastric GISTs by EUS, from January 1997 to December 2008 at the National Taiwan University Hospital, Yuan's General Hospital and En Chu Kong Hospital.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hsiu Po Wang, MD	Department of Internal Medicine, National Taiwan University Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D046152	Gastrointestinal Stromal Tumors

Ancestor Terms

ID	Term
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D005770	Gastrointestinal Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided