Prospective Database of Gastrointestinal Stromal Cell Tumors (GISTs)

NCT ID: NCT02147145

Last Updated: 2014-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

187 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2014-01-31

Brief Summary

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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

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Conditions

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Gastrointestinal Stromal Cell Tumors Foregut Subepithelial Lesions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observation Cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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ProGIST 1

Identifier Type: -

Identifier Source: org_study_id

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