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Esophageal Cancer Risk Registry

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ClinicalTrials.gov Identifier: NCT00260585
Recruitment Status : Recruiting
First Posted : December 1, 2005
Last Update Posted : November 7, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to identify markers in the blood and tissue that could indicate risk factors for the development and progression of esophagus cancer. This research aims to collect medical history, blood, and tissue samples from patients who present with an esophageal disorder. Identifying genetic and behavioral risk factors involved in the development of esophageal cancer might allow for early detection and prevention. Survival and an opportunity for a cure with esophageal cancer will depend greatly on the stage of diagnosis. Tumors can develop changes in their genetic (hereditary) make-up, and these changes can sometimes be seen in normal tissues before the development of cancer. These genetic (hereditary) changes can serve as tumor markers and can be detected using methods that study changes in genetic material like DNA and RNA. The analysis of proteins can provide additional information. By identifying changes in these molecules that are different or altered in cancer, the investigators can use methods and tests for the detection of these changes.

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

Detailed Description:

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 the surgical procedure 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 for up to one year after your enrollment. Again biopsies for normal patient management will be obtained first.

Study Design

Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Esophageal Cancer Risk Registry
Study Start Date : June 1999
Estimated Primary Completion Date : December 2050
Estimated Study Completion Date : December 2050

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    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 intraoperatively.
    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.

Outcome Measures

Biospecimen Retention:   Samples With DNA
blood, tissue, lymph nodes

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients will be selected from the investigator's clinic.

Inclusion Criteria:

  • Known or suspected esophageal or gastroesophageal junction malignancy
  • Known Barrett's metaplasia
  • Clinical management of symptomatic gastroesophageal reflux disease (GERD)
  • Achalasia
  • Hiatal hernia

Exclusion Criteria:

  • Elevated pre-operative bloodwork will not have the additional biopsies taken.
  • Platelet count less than 150,000, partial thromboplastin time (PTT) of 50 or above, and/or International Normalized Ratio (INR) of 1.8 or above will not have the additional biopsies taken.
Contacts and Locations

Information from the National Library of Medicine

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, BSN 412-647-8583 wardj@upmc.edu
Contact: Margaret Reamer, BSN 412-623-3776 reamermm@upmc.edu

United States, Pennsylvania
Department of Cardiothoracic Surgery Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Julie Ward, BSN    412-647-8583    wardj@upmc.edu   
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         
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Principal Investigator: James D. Luketich, MD Department of Cardiothoracic Surgery
More Information

Responsible Party: James Luketich, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00260585     History of Changes
Other Study ID Numbers: 990507
1R01CA208599-01A1 ( U.S. NIH Grant/Contract )
5R01CA090665-09 ( U.S. NIH Grant/Contract )
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by James Luketich, University of Pittsburgh:
gastroesophageal reflux disease
hiatal hernia
Barrett's metaplasia
Anti-Reflux Surgery
Known/suspected esophageal/gastroesophageal junction tumor
Esophageal disorders such as Barrett's metaplasia
Symptomatic gastroesophageal reflux disease

Additional relevant MeSH terms:
Hernia, Hiatal
Esophageal Neoplasms
Gastroesophageal Reflux
Esophageal Achalasia
Esophageal Diseases
Pathological Conditions, Anatomical
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Esophageal Motility Disorders
Deglutition Disorders
Hernia, Diaphragmatic