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Familial Barrett's Esophagus
This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), December 2008
First Received: February 6, 2006   Last Updated: December 1, 2008   History of Changes
Sponsors and Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University Hospitals of Cleveland
Case Western Reserve University
The Cleveland Clinic
Department of Veterans Affairs
Creighton University Medical Center
Fred Hutchinson Cancer Research Center
University of Washington
Mercy Medical Center
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00288119
  Purpose

This is a multi-center study whose aim is to define the epidemiology and genetics of Barrett's esophagus and adenocarcinoma. The researchers have studied families affected with Barrett's esophagus and esophageal adenocarcinoma, a specific type of cancer of the esophagus. They have found that Barrett's and esophageal cancer occur at a younger age in these families suggesting that familial Barrett's esophagus is a genetically inherited disease.


Condition
Barrett's Esophagus
Esophageal Neoplasm

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders
U.S. FDA Resources
Study Type: Observational
Study Design: Family-Based, Cross-Sectional
Official Title: Familial Barrett's Esophagus

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Blood Samples are required to be sent to our NIH approved Biorepository and this repository is designed to help all researchers performing studies on the genetic basis of diseases.


Estimated Enrollment: 1000
Study Start Date: October 2005
Estimated Study Completion Date: September 2010
Detailed Description:

This research study is trying to determine whether Barrett's esophagus and associated esophageal cancers, specifically esophageal adenocarcinoma are inherited in certain families. Persons who are affected with Barrett's esophagus or esophageal cancer (adenocarcinoma type) are asked to complete a questionnaire that determines their habits and asks a detailed family history. Family members of patients seen at University Hospitals of Cleveland and the Cleveland Clinic are also being recruited for screening tests of their esophagus. The investigators plan to eventually screen family members at all participating institutions. This research will eventually lead to the identification of inherited genetic changes that cause Barrett's esophagus and esophageal cancer. It will help the investigators develop better methods for preventing or identifying esophageal cancer at an early curable stage.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Individuals with Barrett's esophagus or adenocarcenoma of the esophagus whose medical care is at the participating institutions, are referred from outside institutions, or who contact the participating institutions.

Criteria

Eligible cases will be defined as those patients and their family members who meet the following criteria:

  • Barrett's esophagus confirmed by review of pathology and endoscopy report or adenocarcinoma of the esophagus or family members of person with Barrett's esophagus or adenocarcinoma of the esophagus.
  • Male or female age 18 or older at time of enrollment or male or female less than 18 years of age at time of enrollment with parental consent.
  • Ability to give informed consent, if patient is age 18 or older.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288119

Contacts
Contact: Amitabh Chak, MD 216-844-5385 axc22@po.cwru.edu
Contact: Wendy Brock, RN 216-844-3853 wendy.brock@UHhospitals.org

Locations
United States, Nebraska
Creighton University Medical Center Recruiting
Omaha, Nebraska, United States, 68131
Contact: Sumeet Mittal, MD     402-280-4161     SumeetMittal@creighton.edu    
Contact: Shannon Staton, PA-C     (402) 280-4526     ShannonStaton@creighton.edu    
Principal Investigator: Sumeet Mittal, MD            
United States, Ohio
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106-8066
Contact: Amitabh Chak, MD     216-844-5386     axc22@po.cwru.edu    
Contact: Wendy Brock, RN     216-844-3853     wendy.brock@UHhospitals.org    
Principal Investigator: Amitabh Chak, MD            
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Gary W. Falk, MD     216-444-1762     falkg@ccf.org    
Contact: Mary Oldenburgh, RN     216-444-8562     oldenbm@ccf.org    
Principal Investigator: Gary W. Falk, MD            
Northeastern Ohio University College of Medicine, Mercy Medical Center Recruiting
Canton, Ohio, United States, 44718
Contact: James King, MD     330-305-2020 ext 465     jfjk@aol.com    
Contact: Linda Chessler     330-936-5815     craigo16@juno.com    
Principal Investigator: James King, MD            
Cleveland Veterans Administration Medical Center - Wade Park Recruiting
Cleveland, Ohio, United States, 44106
Contact: Margaret Kinnard, MD     216-791-3800 ext 3769     Margaret.kinnard@med.va.gov    
Contact: Anna Haas, RN     216-791-3800 ext 3695     anna.haas@va.gov    
Principal Investigator: Margaret Kinnard, MD            
United States, Washington
Fred Hutchinson Cancer Research Center, UWMC Recruiting
Seattle, Washington, United States, 98109
Contact: William Grady, MD     206-667-1107     wgrady@fhcrc.org    
Contact: Kasey Orlowski     206-667-1997     Korlowsk@fhcrc.org    
Principal Investigator: William Grady, MD            
Principal Investigator: Brain Reid, MD            
Sponsors and Collaborators
University Hospitals of Cleveland
Case Western Reserve University
The Cleveland Clinic
Creighton University Medical Center
Fred Hutchinson Cancer Research Center
University of Washington
Mercy Medical Center
Investigators
Principal Investigator: Amitabh Chak, MD University Hospitals of Cleveland, CWRU, Cleveland, OH
Principal Investigator: Gary W Falk, MD, MS The Cleveland Clinic Foundation, Cleveland, OH
Principal Investigator: William Grady, MD Fred Hutchinson Cancer Research Center, UWMC, Seattle, WA
Principal Investigator: James King, MD Northeastern Ohio University College of Medicine, Mercy Medical Center, Canton, OH
Principal Investigator: Margaret Kinnard, MD VA Medical Center - Wade Park
Principal Investigator: Sumeet Mittal, M.D. Creighton University Medical Center
  More Information

No publications provided

Responsible Party: Familial Barrett's Esophagus Consortium ( Dr. Amitabh Chak, M.D., Prinicipal Investigator Dr. Gary Falk, M.D. , MS Principal Investigator )
Study ID Numbers: DK61426, NIH IK24DK02800
Study First Received: February 6, 2006
Last Updated: December 1, 2008
ClinicalTrials.gov Identifier: NCT00288119     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Barrett's Esophagus

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Esophageal Cancer
Digestive System Abnormalities
Digestive System Diseases
Esophageal Disorder
Barrett Syndrome
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Barrett Esophagus
Esophageal Diseases
Congenital Abnormalities

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Digestive System Abnormalities
Gastrointestinal Diseases
Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Barrett Esophagus
Esophageal Diseases

ClinicalTrials.gov processed this record on May 07, 2009