NCT02147145

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

Enrollment Period

4 years

First QC Date

May 21, 2014

Last Update Submit

May 23, 2014

Conditions

Gastrointestinal Stromal Cell TumorsForegut Subepithelial Lesions

Keywords

GISTendoscopyendoscopic ultrasound

Outcome Measures

Primary Outcomes (1)

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

    3 years

Secondary Outcomes (3)

  • 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

Study Arms (1)

Observation Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2014

First Posted

May 26, 2014

Study Start

August 1, 2008

Primary Completion

August 1, 2012

Study Completion

January 1, 2014

Last Updated

May 26, 2014

Record last verified: 2014-05

Locations

US(1)