View Clinical Trial (Medical Research Study)
Esophageal Cancer Risk Registry
| City: |
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Pittsburgh |
| State: |
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Pennsylvania |
| Zip Code: |
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15232 |
| Conditions: |
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Esophageal Cancer - Gastroesophageal Reflux Disease - Esophageal Diseases - Hiatal Hernia - Esophageal Achalasia |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT00260585 |
| Primary Contact: |
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Principal Investigator
James D. Luketich, MD
Department of Cardiothoracic Surgery
Julie A Ward, BSN
Phone: 412-647-8583
Email: wardj@upmc.edu
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| Backup Contact: |
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Email: reamermm@upmc.edu
Margaret Reamer, BSN
Phone: 412-623-3776
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| Location Contact: |
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Pittsburgh, Pennsylvania 15232
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 17, 2013 |
| Modifications to this listing: |
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