Esophageal Cytology With FISH in Detecting Esophageal Cancer
Completed · Not applicable
Conditions studied: Dysphagia, Dysplasia, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Esophagitis, Gastroesophageal Reflux Disease, High Grade Dysplasia in Barrett Esophagus, Weight Loss
In brief
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.
Key facts
- Study ID
- NCT02100189
- Run by
- OHSU Knight Cancer Institute
- People needed
- 50
- Starts
- 2014-02-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2017-05-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects with known esophageal cancer diagnosed by previous endoscopy
- Adenocarcinoma
- Squamous cell carcinoma
- Patients determined to be at risk for esophageal cancer:
- Subjects with a history of Barrett's esophagus
- Subjects with a history of low or high grade dysplasia
- Subjects with a history of gastroesophageal reflux disease (GERD)
- Subjects with a history of esophagitis
- Subjects with symptoms of esophageal cancer (EC) referred for endoscopy (new onset dysphagia, weight loss, etc)
- Patients must be scheduled for a procedure capable of providing a definitive pathological diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either:
- Upper endoscopy
- Surgical esophagectomy
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status =< 3 (Karnofsky >= 30%) will be included
- Ability to understand and the willingness to sign a written informed consent document
You may not qualify if…
- Subjects with severe, symptomatic dysphagia (unable to pass solids)
- Subjects that are unable to swallow a tablet/pill for any reason
- Subjects with a previous esophagectomy
- Subjects with esophageal varices
- Subjects unable to provide consent
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Where it is running
- OHSU Knight Cancer Institute — Portland, Oregon, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.