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| Sponsor: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Collaborators: |
University Hospitals of Cleveland Case Western Reserve University Department of Veterans Affairs Creighton University Medical Center 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 |
| 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 |
| Study Type: | Observational |
| Study Design: | Observational Model: Family-Based Time Perspective: Cross-Sectional |
| Official Title: | Familial Barrett's Esophagus |
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 2012 |
| Estimated Primary Completion Date: | September 2012 (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 |
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.
Eligible cases will be defined as those patients and their family members who meet the following criteria:
Contacts and Locations| Contact: Amitabh Chak, MD | 216-844-5385 | axc22@po.cwru.edu |
| Contact: Wendy Brock, RN | 216-844-3853 | wendy.brock@UHhospitals.org |
| United States, Maryland | |
| Johns Hopkins Hospital | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Contact: Marcia Canto, M.D. 410-614-5388 | |
| Contact: Verna Scheeler, MLA (410) 502-9795 vscheele@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, 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, 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: Norma Daugherty (919) 843-9616 norma_daugherty@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 | |
| 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 | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: John Vargo, MD 216-444-1000 jvargo@ccf.org | |
| Principal Investigator: John Vargo, MD | |
| Principal Investigator: John Dumont, M.D. | |
| 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, 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: Julie Starr, RN 215-573-1865 jstarr@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 | |
| 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. | The Cleveland Clinic |
| Principal Investigator: | John Vargo, M.D. | The Cleveland Clinic |
| Principal Investigator: | Rom Leidner, Ph.D. | Case Western Reserve University |
More Information
| Responsible Party: | Dr. Amitabh Chak, M.D., Prinicipal Investigator Dr. Gary Falk, M.D. , MS Principal Investigator, Familial Barrett's Esophagus Consortium |
| ClinicalTrials.gov Identifier: | NCT00288119 History of Changes |
| Other Study ID Numbers: | RO1DK070863, NIH IK24DK02800 |
| Study First Received: | February 6, 2006 |
| Last Updated: | April 14, 2011 |
| Health Authority: | United States: Federal Government |
|
Barrett's Esophagus |
|
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 |
