RecruitingNCT00260585

Esophageal Cancer Risk Registry


Sponsor

University of Pittsburgh

Enrollment

7,000 participants

Start Date

Jun 1, 1999

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

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

Exclusion Criteria2

  • 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.

Interventions

PROCEDURESurvey of client health, personal habits, family history

A questionnaire is administered at the time of consent.

PROCEDUREBlood 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

PROCEDUREBiopsy of esophageal/stomach tissue, lymph nodes, tumor

Tissue from the biopsies is collected intraoperatively.

PROCEDUREBiopsies, oral (saliva) and/or secretions, washings or mucosal scrapings/brushing from routine clinical surveillance endoscopies

Tissue from the biopsies, oral (saliva) and/or secretions, washings or mucosal scrapings/brushings are collected intraoperatively.


Locations(1)

Department of Cardiothoracic Surgery

Pittsburgh, Pennsylvania, United States

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NCT00260585


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