Weight Loss Clinical Trial
Official title:
Esophageal Cancer (10030139, 10066354) Screening With FISH in Esophageal Cytology
This clinical trial studies whether esophageal cytology plus fluorescence in situ hybridization (FISH) is equal to or better than esophago-gastro-duodenoscopy (EGD) or upper endoscopy for the early detection of esophageal cancer. Genes are the units of deoxyribonucleic acid (DNA) the chemical structure carrying genetic information that determine many human characteristics. Certain genes in cancer cells may determine how the tumor grows or spreads and how it may respond to different drugs. Part of this study is to test those genes in esophageal cells using FISH.
PRIMARY OBJECTIVES:
I. Determine if sponge cytology with FISH is a reliable screening tool for esophageal
dysplasia/cancer, and determine its sensitivity and specificity, compared to the gold
standard procedure (upper endoscopy).
SECONDARY OBJECTIVES:
I. Determine if the cytology screening with FISH biomarkers is more cost effective than
upper endoscopy for the screening of esophageal cancer and the surveillance of esophageal
metaplasia and dysplasia.
II. Determine the limitations and future needs to improve this technique.
OUTLINE:
Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the
sponge is pulled out through the esophagus by gentle traction on the string. Cytology
samples from the sponge are harvested and analyzed by FISH. Participants then undergo
standard EGD or upper endoscopy.
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