Esophageal Cancer Risk Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00260585
First received: November 28, 2005
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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 Intervention
Esophageal Cancer
Gastroesophageal Reflux Disease
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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Esophageal Cancer Risk Registry

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Biospecimen Retention:   Samples With DNA

blood, tissue, lymph nodes


Estimated Enrollment: 4500
Study Start Date: June 1999
Estimated Study Completion Date: December 2050
Estimated Primary Completion Date: December 2050 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Eligible patients will be selected from the investigator's clinic.

Criteria

Inclusion Criteria:

  • Known or suspected esophageal or gastroesophageal junction malignancy
  • Known Barrett's metaplasia
  • Clinical management of symptomatic gastroesophageal reflux disease
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260585

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

Locations
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: Rodney Landreneau, MD         
Sub-Investigator: Neil Christie, MD         
Sub-Investigator: Matthew Schuchert, MD         
Sub-Investigator: Arman Kilic         
Sub-Investigator: Katie Nason, MD         
Sub-Investigator: Lawrence Crist, MD         
Sub-Investigator: Michael Gibson, MD         
Sub-Investigator: Alyssa Krasinskas, MD         
Sub-Investigator: Scott Owens, MD         
Sub-Investigator: Ghulam Abbas, MD         
Sub-Investigator: Arjun Pennathur, MD         
Sub-Investigator: Manisha Shende, MD         
Sub-Investigator: Benny Weksler, 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: Steven Hughes, MD         
Sub-Investigator: Jason Lamb, MD         
Sub-Investigator: Ali Hussainy Zaidi, MD         
Sub-Investigator: Vera Donnenberg, PhD         
Sub-Investigator: Joel Weissfeld, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: James D. Luketich, MD Department of Cardiothoracic Surgery
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00260585     History of Changes
Other Study ID Numbers: 990507
Study First Received: November 28, 2005
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
gastroesophageal reflux disease
GERD
hiatal hernia
achalasia
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:
Esophageal Achalasia
Esophageal Diseases
Esophageal Neoplasms
Gastroesophageal Reflux
Hernia
Hernia, Hiatal
Esophageal Motility Disorders
Deglutition Disorders
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Pathological Conditions, Anatomical
Hernia, Diaphragmatic

ClinicalTrials.gov processed this record on July 23, 2014