BETERNet Notch Signaling and Novel Biomarkers for Barretts Esophagus

NCT01484925 | Completed DMC

• 1 other identifier: UPCC 22211
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Barrett's Esophagus

Keywords

Barrett's esophagus

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Gary Falk, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 5, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: December 5, 2019

Record last verified: 2019-12

Locations

US (1)