Prospective Database of Gastrointestinal Stromal Cell Tumors (GISTs)

May 23, 2014 updated by: Washington University School of Medicine

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

187

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients (>18 years of age) referred for EUS evaluation of incidentally discovered foregut SEL at a two tertiary care centers between 8/2008 and 8/2012.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Observation Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the natural history of small (< 30 mm) SELs discovered evaluated by EUS.
Time Frame: 3 years
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

May 23, 2014

First Posted (Estimate)

May 26, 2014

Study Record Updates

Last Update Posted (Estimate)

May 26, 2014

Last Update Submitted That Met QC Criteria

May 23, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ProGIST 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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