Cell Marker Predictors in Barrett's Esophagus

• Sponsor: The Guthrie Clinic (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03316053
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Anticipated Duration (Months): 60.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus Without Dysplasia	Other: Tissue sample for genetic testing

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 25 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Cell Marker Predictors in Barrett's Esophagus
• Actual Study Start Date: Nov 15, 2017
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Tissue Sample for genetic testing Biopsy sample	Other: Tissue sample for genetic testing; Tissue sample to be obtained during routine endoscopy

Outcome Measures

Primary Outcome Measures

1. Cell Markers [through study completion, an average of 1 year]

   Identify genes involved in Barrett's Esophagus

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Guthrie Clinic	Sayre	Pennsylvania	United States	18840

Sponsors and Collaborators

• The Guthrie Clinic

Investigators

• Principal Investigator: John Ford, MD, The Guthrie Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Guthrie Clinic
• ClinicalTrials.gov Identifier: NCT03316053
• Other Study ID Numbers: 1708-43
• First Posted: Oct 20, 2017
• Last Update Posted: Feb 3, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Barrett Esophagus

Study Results

No Results Posted as of Feb 3, 2021