Prospective Database of Gastrointestinal Stromal Cell Tum... | NCT02147145

Studies
Prospective Database of Gastrointestinal Stromal Cell Tumors (GISTs)

NCT02147145

Sponsor

Washington University School of Medicine

Status

Completed

Last Update Posted

May 26, 2014Estimated

Enrollment

187Actual

Phase

Not provided

Conditions

Gastrointestinal Stromal Cell Tumors
Foregut Subepithelial Lesions

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Aug 2012Actual

Completion Date

Jan 2014Actual

First Submitted Date

May 21, 2014

First Submission Date that Met QC Criteria

May 23, 2014

First Posted Date

May 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2014

Last Update Posted Date

May 26, 2014Estimated

Name	Class
Northwestern University	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

187Actual

Label	Type	Description	Intervention Names
Observation Cohort

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Determine the degree of patient compliance with surveillance recommendations.		3 years
Describe the diagnostic yield of EUS±FNA in evaluating SELs.		2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University		Chicago	Illinois	60611	United States