Impact of Cellular Markers on Clinical Response after Treatment for Esophageal Cancer

Principal Investigator: James Dolan, MD

What is the purpose of this study?

We are attempting to improve the treatment process for patients with esophageal cancer. This cancer is increasing in incidence and is difficult to treat or cure which leads to poor survival even after current treatment with chemotherapy, radiation and surgery. In this study, we will use cancer tissue that is already available to us to test for the presence of a specific group of cancer cell markers that have been, individually, found to predict either good or poor outcomes after the treatment of esophageal cancer.

Why do this study?

Tissue from biopsies of patients with esophageal cancer will be the only tissue used for testing. One group will comprise tissue from patients who are known to have responded well to medical and surgical treatment and the other group will use tissue derived from patients who are known to have responded poorly to medical and surgical treatment. Tissue from each group will be tested for the presence of a defined group of cell markers that have been individually linked to good or poor outcomes after treatment of esophageal cancer. The two groups will then be compared in regard to the measured levels of the markers present on the cancer cells and we will attempt to determine, by direct comparison of the two groups, what arrangement of cell markers predict a good or a bad outcome after treatment.

Who will be included?

This study will use the tissue and data that have already been collected from esophageal cancer patients and stored in the Natural History of Esophageal Cancer and Related Diseases (ECRD) tissue bank (eIRB #1759). We would also like to obtain tissue and limited (non-PHI related) information from non-consented subjects by utilizing a Waiver of Authorization.

What is involved?

All esophageal cancer patients are currently approached to join the ECRD (IRB1759) study during the course of their treatment at OHSU. Those who choose to join the study are evaluated and treated according to current medical and surgical standards of care in order to attempt to cure them of their cancers. As part of the ECRD study, tissue gathered during pre-treatment biopsy and postoperative surgical specimens are currently stored in the ECRD tissue bank. Portions of this tissue will be used in this proposed study and will be tested for the presence of a certain set of cell markers. Subject study data will be collected by the ECRD as part of their routine study practice. In addition, esophageal tissue and subject data will be gathered on subjects who have had an esophageal surgical procedure for esophageal cancer at OHSU. For these non-consented subjects, a Waiver of Authorization will be obtained from the OHSU IRB. No personal health information will be collected on non-consented subjects. Subjects will not be contacted as part of this study. Subjects are assigned a unique identifier which is linked to the subject tissue id number. Specific data variables will be requested from the ECRD or queried from OHSU medical records. All data transfers will occur using a shared secure network server.