BETERNet Notch Signaling and Novel Biomarkers for Barretts Esophagus

Sponsor

Abramson Cancer Center of the University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT01484925

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research study hopes to identify new molecular markers in the tissue of Barrett's esophagus that will help physicians better understand and manage this condition. Patients undergoing an upper endoscopy will be asked to complete a gastroesophageal reflux disease (GERD) questionnaire, provide a blood sample and allow additional biopsies to be taken during the procedure.

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus

Detailed Description

This research study hopes to identify new molecular markers in the tissue of Barrett's esophagus that will help physicians better understand and manage this condition. Currently there is very little understanding as to how Barrett's esophagus develops and why some people with Barrett's esophagus go on to develop esophageal cancer. The purpose of this study is to develop a better understanding of how these processes occur. The investigators also hope to use the information from this study to identify new molecular markers that the investigators can use to better determine who will or will not go on to develop esophageal cancer. Patients who have been diagnosed in the past with Barrett's esophagus will be asked to participate. Patients without Barrett's esophagus will be asked to take part so that the investigators can compare tissue from patients without the conditions to those with the conditions.

Study Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Notch Signaling and Novel Biomarkers for Barretts Esophagus

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Nov 1, 2018

Actual Study Completion Date :

Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
With Barrett's Esophagus Patients who have been diagnosed in the past with Barrett's Esophagus
Without Barrett's Esophagus Patients without Barrett's Esophagus will be asked to take part so that comparison can be made with patients' tissue for those with the condition and those without the condition.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

For BE patients:

History of histologically confirmed BE, defined as endoscopically-suspected BE with intestinal metaplasia with globlet cells on esophageal biopsies,
BE length C1M1 or C0M2
Age 18 years

Exclusion Criteria:

History of gastric or esophageal surgery
Inability to give informed consent
Erosive esophagitis seen on upper endoscopy
History of prior endoscopic therapy for BE 5 (for controls) History of intestinal metaplasia on previous esophageal, GE junction or cardia biopsies.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

Abramson Cancer Center of the University of Pennsylvania

Investigators

Principal Investigator: Gary Falk, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abramson Cancer Center of the University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT01484925

Other Study ID Numbers:

UPCC 22211

First Posted:

Dec 5, 2011

Last Update Posted:

Dec 5, 2019

Last Verified:

Dec 1, 2019

Keywords provided by Abramson Cancer Center of the University of Pennsylvania

Barrett's esophagus

Additional relevant MeSH terms:

Barrett Esophagus

Study Results

No Results Posted as of Dec 5, 2019