Esophageal Cancer Risk Registry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00260585|
Recruitment Status : Recruiting
First Posted : December 1, 2005
Last Update Posted : November 8, 2018
|Condition or disease||Intervention/treatment|
|Esophageal Cancer Gastroesophageal Reflux Disease (GERD) Esophageal Diseases Hiatal Hernia Esophageal Achalasia||Procedure: Survey of client health, personal habits, family history Procedure: Blood specimen for non-DNA and DNA parts Procedure: Biopsy of esophageal/stomach tissue, lymph nodes, tumor Procedure: Biopsies from routine clinical surveillance endoscopies|
We will enroll patients with esophageal cancer, patients who are at risk for developing esophageal cancer, and patients who have a non-cancerous esophageal disorder. All patients will be asked to fill out a questionnaire about their general health and personal habits, and about their relatives' medical history; this will be done during the preoperative clinic visit. Prior to or at the time of the surgical procedure(s), and at the time of routine follow-up visits, a sample of blood (about 3 tablespoons) will be drawn for research.
For patients undergoing an endoscopy after the normal biopsies are taken, several small samples will be taken from the esophagus and stomach. These should total no more than eight samples.
For patients undergoing an anti-reflux procedure with or without a Collis gastroplasty a lymph node is normally removed. We will receive a small piece of that lymph node after the pathologist has done the routine pathological evaluation of that node.
If the collis procedure is done, a new esophagus is formed and a small piece of stomach tissue is discarded. We will study the ordinarily discarded tissue for the transformation of cells from a normal to an abnormal state. The lymph node and stomach tissue will be collected only once for the study.
For patients undergoing an esophagectomy (removal of the esophagus) or a staging procedure (performed to determine size, exact location, and spread of tumor to nearby areas) prior to an esophagectomy small pieces of tissue will be collected (from tumor, adjacent normal esophageal lining, parts of lymph nodes, and any other tissues removed as a part of the normal procedure) from your esophagectomy or staging specimens. This tissue will be collected only once for the study. The samples collected will be analyzed for genetic changes in the DNA and the RNA. The samples will be stored in a locked laboratory at the Hillman Cancer Center Research Pavilion indefinitely or until the samples are depleted.
You may be contacted in the future to learn the results of any cancer screening tests you had undergone and whether anyone else in your family had developed cancer. This information will be entered in a computer data base for future study.
We may continue to collect additional biopsies during your routine clinical surveillance endoscopies. Again biopsies for normal patient management will be obtained first.
|Study Type :||Observational|
|Estimated Enrollment :||6000 participants|
|Official Title:||Esophageal Cancer Risk Registry|
|Study Start Date :||June 1999|
|Estimated Primary Completion Date :||December 2050|
|Estimated Study Completion Date :||December 2050|
- Procedure: Survey of client health, personal habits, family history
A questionnaire is administered at the time of consent.
- Procedure: Blood specimen for non-DNA and DNA parts
Blood specimen is collected prior to surgery or at the time of scheduled routine surgical procedure(s), and at the time of routine follow-up visits
- Procedure: Biopsy of esophageal/stomach tissue, lymph nodes, tumor
Tissue from the biopsies is collected intraoperatively.
- Procedure: Biopsies from routine clinical surveillance endoscopies
Tissue from the biopsies is collected intraoperatively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260585
|Contact: Julie A Ward, BSNemail@example.com|
|Contact: Judy Forster, BSNfirstname.lastname@example.org|
|United States, Pennsylvania|
|Department of Cardiothoracic Surgery||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Julie Ward, BSN 412-647-8583 email@example.com|
|Principal Investigator: James Luketich, MD|
|Sub-Investigator: Neil Christie, MD|
|Sub-Investigator: Matthew Schuchert, MD|
|Sub-Investigator: Katie Nason, MD|
|Sub-Investigator: Lawrence Crist, DO|
|Sub-Investigator: Arjun Pennathur, MD|
|Sub-Investigator: Manisha Shende, MD|
|Sub-Investigator: Ryan Levy, MD|
|Sub-Investigator: Angela Gallagher, CRNP|
|Sub-Investigator: Omar Awais, DO|
|Sub-Investigator: Robert Schoen, MD|
|Sub-Investigator: James Lyons-Weiler, PhD|
|Sub-Investigator: Jason Lamb, MD|
|Sub-Investigator: Vera Donnenberg, PhD|
|Sub-Investigator: Rajeev Dhupar, MD|
|Sub-Investigator: Inderpal Sarkaria, MD|
|Sub-Investigator: Jonathan D'Cunha, MD|
|Sub-Investigator: Manuel Villa Sanchez, MD|
|Sub-Investigator: Nicholas Baker, MD|
|Sub-Investigator: Olivera Finn, PhD|
|Sub-Investigator: Olugbenga Okusanya, MD|
|Principal Investigator:||James D. Luketich, MD||Department of Cardiothoracic Surgery|