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

Further study details as provided by University of Pittsburgh:

Expected Total Enrollment:  1500

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00260585

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

Pennsylvania
      Heart, Lung, and Esophageal Surgery Institute, Pittsburgh,  Pennsylvania,  15232,  United States; Recruiting

Study chairs or principal investigators

James D. Luketich, MD,  Principal Investigator,  Heart, Lung, and Esophageal Surgery Institute   

Study ID Numbers:  990507
Last Updated:  September 6, 2006
Record first received:  November 28, 2005
ClinicalTrials.gov Identifier:  NCT00260585
Health Authority: United States: Institutional Review Board

 

Esophageal Cancer (National Library of Medicine)

ClinicalTrials.gov: Esophageal Neoplasms  (National Institutes of Health)

Esophageal Cancer (PDQ): Screening  (National Cancer Institute)

Esophageal Cancer (PDQ): Treatment  (National Cancer Institute)

What's New in Esophageal Cancer Research and Treatment?  (American Cancer Society)

Esophageal Cancer (PDQ): Prevention  (National Cancer Institute)

What Are the Risk Factors for Cancer of the Esophagus?  (American Cancer Society)

Esophageal Cancer  (Mayo Foundation for Medical Education and Research)

How Is Cancer of the Esophagus Staged?  (American Cancer Society)

Zinc Deficiency Linked to Increased Risk of Less–Common Form of Esophageal Cancer  (National Cancer Institute)

What Is Cancer of the Esophagus?  (American Cancer Society)

What Are the Key Statistics about Cancer of the Esophagus?  (American Cancer Society)

What Should You Ask Your Doctor about Cancer of the Esophagus?  (American Cancer Society)

Treatment of Cancer of the Esophagus by Stage  (American Cancer Society)

Can Cancer of the Esophagus Be Found Early?  (American Cancer Society)

How Is Cancer of the Esophagus Diagnosed?  (American Cancer Society)

Photodynamic Therapy  (American Cancer Society)

Palliative Therapy  (American Cancer Society)

Barrett's Esophagus  (National Institute of Diabetes and Digestive and Kidney Diseases)

What You Need to Know about Cancer of the Esophagus  (National Cancer Institute)

How Is Cancer of the Esophagus Treated?  (American Cancer Society)

Understanding Esophageal Dilation  (American Society for Gastrointestinal Endoscopy)

Esophagus Cancer: What Happens After Treatment?  (American Cancer Society)