Prospective Database of Gastrointestinal Stromal Cell Tumors (GISTs)

Completed

• Conditions: Gastrointestinal Stromal Cell Tumors; Foregut Subepithelial Lesions

• Registration Number: NCT02147145
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2012-08
• Study Completion: 2014-01
• Status Verified: 2014-05
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-23
• Last Update Submitted: 2014-05-23
• Study First Posted: 2014-05-26
• Last Update Posted: 2014-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the natural history of small (< 30 mm) SELs discovered evaluated by EUS.	3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States