Trials / Completed
CompletedNCT02100189
Esophageal Cytology With FISH in Detecting Esophageal Cancer
Esophageal Cancer (10030139, 10066354) Screening With FISH in Esophageal Cytology
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- OHSU Knight Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Dysphagia
- Dysplasia
- Esophageal Adenocarcinoma
- Esophageal Squamous Cell Carcinoma
- Esophagitis
- Gastroesophageal Reflux Disease
- High Grade Dysplasia in Barrett Esophagus
- Weight Loss
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Cytology Specimen Collection Procedure | Undergo esophageal cytology collection |
| PROCEDURE | Esophagogastroduodenoscopy | Undergo standard EGD or endoscopy |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2014-03-31
- Last updated
- 2017-05-11
- Results posted
- 2017-03-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02100189. Inclusion in this directory is not an endorsement.