Familial Barrett's Esophagus (FBE)
This study is currently recruiting participants.
Verified January 2013 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor:
Collaborators:
University Hospitals of Cleveland
Case Western Reserve University
Creighton University Medical Center
Washington University School of Medicine
Fred Hutchinson Cancer Research Center
University of Washington
Mercy Medical Center
Johns Hopkins University
Mayo Clinic
University of North Carolina, Chapel Hill
The Cleveland Clinic
University of Pennsylvania
Columbia University
Information provided by (Responsible Party):
Amitabh Chak, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00288119
First received: February 6, 2006
Last updated: January 15, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Family-Based Time Perspective: Cross-Sectional |
| Official Title: | Familial Barrett's Esophagus |
Resource links provided by NLM:
Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Biospecimen Retention: Samples With DNA
Detailed 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 2017 |
| Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
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, Maryland | |
| Johns Hopkins Hospital | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Contact: Marcia Canto, M.D. 410-614-5388 | |
| Contact: Hilary Cosby, RN (410) 502-2893 Hcosby1@jhmi.edu | |
| Principal Investigator: Marcia I Canto, M.D. | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Ganapathy A Prasad, M.D. 507-255-6930 Prasad.Ganapathy@Mayo.edu | |
| Contact: Kelly Dunagan (507) 255-8692 Dunagan.Kelly@Mayo.edu | |
| Principal Investigator: Ganapathy A Prasad, M.D. | |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St Louis, Missouri, United States, 63110 | |
| Contact: Jean Wang, MD 314-362-5952 jwang@DOM.wustl.edu | |
| Contact: Thomas Hollander 314-747-1973 tholland@DOM.wustl.edu | |
| Principal Investigator: Jean Wang, MD | |
| United States, Nebraska | |
| Creighton University Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68131 | |
| Contact: Sumeet Mittal, MD 402-280-4161 SumeetMittal@creighton.edu | |
| Contact: Beth Gifford (402) 280-4278 ElizabethGifford@Creighton.edu | |
| Principal Investigator: Sumeet Mittal, MD | |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Julian Abrams, MD 212-342-0476 ja660@mail.cumc.columbia.edu | |
| Contact: Adriana Rodriquez 212-304-5606 | |
| Principal Investigator: Julian Abrams, MD | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Nicholas J Shaheen, M.D. 919-966-2513 nshaheen@med.unc.edu | |
| Contact: Jessica Hores (919) 843-9616 jessica_hores@med.unc.edu | |
| Principal Investigator: Nicholas J Shaheen, M.D. | |
| United States, Ohio | |
| 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 | |
| The Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: John Vargo, MD 216-444-1000 jvargo@ccf.org | |
| Principal Investigator: John Vargo, MD | |
| 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 | |
| Sub-Investigator: John Dumot, 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: Bronia Alashkar 216-791-3800 ext 3695 bronia.alashkar@va.gov | |
| Principal Investigator: Margaret Kinnard, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Gary W Falk, MD, MS 215-615-6588 Gary.Falk@uphs.upenn.edu | |
| Contact: Maureen Demarshall, RN 215-349-8546 demarchm@mail.upenn.edu | |
| Principal Investigator: Gary W. Falk, MD, MS | |
| 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
Creighton University Medical Center
Washington University School of Medicine
Fred Hutchinson Cancer Research Center
University of Washington
Mercy Medical Center
Johns Hopkins University
Mayo Clinic
University of North Carolina, Chapel Hill
The Cleveland Clinic
University of Pennsylvania
Columbia University
Investigators
| Principal Investigator: | Amitabh Chak, MD | University Hospitals of Cleveland, CWRU, Cleveland, OH |
| Principal Investigator: | Gary W Falk, MD, MS | University of Pennsylvania |
| 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 |
| Principal Investigator: | Nicholas J Shaheen, M.D. | University of North Carolina, Chapel Hill |
| Principal Investigator: | Ganapathy Prasad, M.D. | Mayo Clinic |
| Principal Investigator: | Marcia Canto, M.D. | Johns Hopkins University |
| Principal Investigator: | John Dumont, M.D. | University Hospital Case Medical Center |
| Principal Investigator: | John Vargo, M.D. | The Cleveland Clinic |
| Principal Investigator: | Rom Leidner, Ph.D. | Case Western Reserve University |
| Principal Investigator: | Jean Wang, MD | Washington University School of Medicine |
| Principal Investigator: | Julian Abrams, MD | Columbia University |
More Information
No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amitabh Chak, Dr. Amitabh Chak, M.D., Prinicipal Investigator Dr. Gary Falk, M.D. , MS Principal Investigator, Familial Barrett's Esophagus Consortium., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00288119 History of Changes |
| Other Study ID Numbers: | RO1DK070863, NIH IK24DK02800 |
| Study First Received: | February 6, 2006 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
Barrett's Esophagus |
Additional relevant MeSH terms:
|
Barrett Esophagus Neoplasms Esophageal Diseases Esophageal Neoplasms Digestive System Abnormalities Digestive System Diseases |
Gastrointestinal Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013