BETERNet Notch Signaling and Novel Biomarkers for Barretts Esophagus

This study is currently recruiting participants.

Verified December 2011 by Abramson Cancer Center of the University of Pennsylvania

Sponsor:

Information provided by (Responsible Party):

Abramson Cancer Center of the University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT01484925

First received: December 1, 2011

Last updated: December 8, 2011

Last verified: December 2011

History of Changes

Purpose

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
Barrett's Esophagus

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Notch Signaling and Novel Biomarkers for Barretts Esophagus

Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Estimated Enrollment:	60
Study Start Date:	November 2011
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients with Barretts Esophagus with and without associated dysplasia or cancer and controls with and without gastro-esophageal reflux.

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484925

Contacts

Contact: Maureen DeMarshall

215-349-8546

demarshm@mail.med.upenn.edu

Locations

United States, Pennsylvania
Abramson Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maureen DeMarshall 215-349-8546 demarshm@mail.med.upenn.edu

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

More Information

No publications provided

Responsible Party:	Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT01484925 History of Changes
Other Study ID Numbers:	UPCC 22211
Study First Received:	December 1, 2011
Last Updated:	December 8, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:

Barrett's esophagus

Additional relevant MeSH terms:

Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on June 18, 2013

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