Esophageal Cancer Risk Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Known or suspected esophageal or gastroesophageal junction malignancy

Known Barrett's metaplasia

Clinical management of symptomatic gastroesophageal reflux disease (GERD)

Achalasia

Disqualifiers

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.

Trial population

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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Survey of client health, personal habits, family history

    Procedure/Surgery

    A questionnaire is administered at the time of consent.

  • Blood specimen for non-DNA and DNA parts

    Procedure/Surgery

    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

  • Biopsy of esophageal/stomach tissue, lymph nodes, tumor

    Procedure/Surgery

    Tissue from the biopsies is collected intraoperatively.

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

    Procedure/Surgery

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

Treatment groups

No treatment groups listed

Trial outcomes

This trial has no outcomes listed.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pittsburgh

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator