BETERNet Notch Signaling and Novel Biomarkers for Barretts Esophagus

NCT ID: NCT01484925

Last Updated: 2019-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2018-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Barrett's Esophagus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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With Barrett's Esophagus

Patients who have been diagnosed in the past with Barrett's Esophagus

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gary Falk, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

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Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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UPCC 22211

Identifier Type: -

Identifier Source: org_study_id

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