Cell Marker Predictors in Barrett's Esophagus | NCT03316053

Studies
Cell Marker Predictors in Barrett's Esophagus

NCT03316053

Sponsor

The Guthrie Clinic

Status

Active, not recruiting

Last Update Posted

Jan 7, 2026Actual

Enrollment

25Estimated

Phase

Not provided

Conditions

Barrett's Esophagus Without Dysplasia

Interventions

Tissue sample for genetic testing

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

Jan 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2017Actual

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Dec 1, 2027Estimated

First Submitted Date

Oct 16, 2017

First Submission Date that Met QC Criteria

Oct 18, 2017

First Posted Date

Oct 20, 2017Actual

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

Jan 5, 2026

Last Update Posted Date

Jan 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to analyze biopsied tissue samples for changes in cells and genes involved in Barrett's Esophagus.

Detailed Description

Patients with a history of Barrett's esophagus who are scheduled for a routine endoscopy will have an additional biopsy taken for genetic testing.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tissue Sample for genetic testing		Biopsy sample	Other: Tissue sample for genetic testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tissue sample for genetic testing	Other	Tissue sample to be obtained during routine endoscopy	Tissue Sample for genetic testing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cell Markers	Identify genes involved in Barrett's Esophagus	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

History of Barrett's esophagus; scheduled for routine upper endoscopy

Exclusion Criteria:

Under 18 years of age
Unable to consent on own behalf

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

Patients with a history of Barrett's esophagus

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Georgetson, MD	The Guthrie Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Guthrie Clinic		Sayre	Pennsylvania	18840	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006650	Histocompatibility Testing
D005820	Genetic Testing

Ancestor Terms

ID	Term
D007159	Immunologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided