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OpenTrials
Completed

NCT Number: NCT02147145

Prospective Database of Gastrointestinal Stromal Cell Tumors (GISTs)

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.

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Key information

Conditions

Gastrointestinal Stromal Cell Tumors Foregut Subepithelial Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 3 years

Secondary outcomes

  1. Determine the degree of patient compliance with surveillance recommendations.

    Time frame: 3 years

  2. Describe the diagnostic yield of EUS±FNA in evaluating SELs.

    Time frame: 2 weeks

  3. Compare SEL size estimation based on EUS, EGD and computer tomography (CT).

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Northwestern University

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2014
First posted
May 26, 2014
Registry last updated
May 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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