NCT03316053

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
19mo left

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress84%
Nov 2017Dec 2027

First Submitted

Initial submission to the registry

October 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

November 15, 2017

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

9 years

First QC Date

October 16, 2017

Last Update Submit

January 5, 2026

Conditions

Barrett's Esophagus Without Dysplasia

Outcome Measures

Primary Outcomes (1)

  • Cell Markers

    Identify genes involved in Barrett's Esophagus

    through study completion, an average of 1 year

Study Arms (1)

Tissue Sample for genetic testing

Biopsy sample

Other: Tissue sample for genetic testing

Interventions

Tissue sample for genetic testingOTHER

Tissue sample to be obtained during routine endoscopy

Tissue Sample for genetic testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a history of Barrett's esophagus

You may qualify if:

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

You may not qualify if:

  • Under 18 years of age
  • Unable to consent on own behalf

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Guthrie Clinic

Sayre, Pennsylvania, 18840, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biopsy during endoscopy

MeSH Terms

Interventions

Histocompatibility TestingGenetic Testing

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Michael Georgetson, MD

    The Guthrie Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 20, 2017

Study Start

November 15, 2017

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)