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Spots Global Cancer Trial Database for Esophageal Cytology With FISH in Detecting Esophageal Cancer

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Trial Identification

Brief Title: Esophageal Cytology With FISH in Detecting Esophageal Cancer

Official Title: Esophageal Cancer (10030139, 10066354) Screening With FISH in Esophageal Cytology

Study ID: NCT02100189

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

OHSU Knight Cancer Institute, Portland, Oregon, United States

Contact Details

Name: John Hunter

Affiliation: OHSU Knight Cancer Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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