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BETERNet Notch Signaling and Novel Biomarkers for Barretts Esophagus

This study is currently recruiting participants.
Verified January 2017 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
ClinicalTrials.gov Identifier:
NCT01484925
First Posted: December 5, 2011
Last Update Posted: January 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
  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 Primary Completion Date: November 2017 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01484925     History of Changes
Other Study ID Numbers: UPCC 22211
First Submitted: December 1, 2011
First Posted: December 5, 2011
Last Update Posted: January 25, 2017
Last Verified: January 2017

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