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Prospective Database of Gastrointestinal Stromal Cell Tumors (GISTs)

Prospective Database of Gastrointestinal Stromal Cell Tumors (GISTs)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02147145
Enrollment
187
Registered
2014-05-26
Start date
2008-08-31
Completion date
2014-01-31
Last updated
2014-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foregut Subepithelial Lesions, Gastrointestinal Stromal Cell Tumors

Keywords

GIST, endoscopy, endoscopic ultrasound

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.

Interventions

None listed

Sponsors

Northwestern University
CollaboratorOTHER
Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Determine the natural history of small (< 30 mm) SELs discovered evaluated by EUS.3 years

Secondary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026