Prospective Database of Gastrointestinal Stromal Cell Tumors (GISTs)

Washington University School of Medicine1 site in 1 country187 target enrollmentAugust 2008

ConditionsGastrointestinal Stromal Cell Tumors Foregut Subepithelial Lesions

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gastrointestinal Stromal Cell Tumors
Sponsor: Washington University School of Medicine
Enrollment: 187
Locations: 1
Primary Endpoint: Determine the natural history of small (< 30 mm) SELs discovered evaluated by EUS.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Specific Aim 1: To determine patient compliance with a GIST surveillance program Hypothesis: Patient compliance with a GIST surveillance program will be low.

Specific Aim 2: To determine if EUS features of GIST, particularly maximum size, change significantly during a surveillance program.

Hypothesis: EUS features of GIST, particularly maximum size, will not change significantly during a surveillance program.

Specific Aim 3: To determine if EGD measures of GIST size correlate well with EUS measures of GIST size.

Hypothesis: EGD measures of GIST size will correlate well with EUS measured of GIST size.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

January 2014

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Washington University School of Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•presenting for EUS with an indication for a SEL in the stomach or esophagus
•at least 18 years of age
•able to provide informed consent

Exclusion Criteria

•no subepithelial lesion in the stomach or esophagus'
•less than 18 years of age
•unable to provide informed consent

Outcomes

Primary Outcomes

Determine the natural history of small (< 30 mm) SELs discovered evaluated by EUS.

Time Frame: 3 years

Secondary Outcomes

Determine the degree of patient compliance with surveillance recommendations.(3 years)
Describe the diagnostic yield of EUS±FNA in evaluating SELs.(2 weeks)
Compare SEL size estimation based on EUS, EGD and computer tomography (CT).(1 day)