N/A
N=50
Esophageal Cytology With FISH in Detecting Esophageal Cancer
Dysphagia · Dysplasia · Esophageal Adenocarcinoma · Esophageal Squamous Cell Carcinoma · Esophagitis
Bottom Line
View on ClinicalTrials.gov: NCT02100189 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Sensitivity of Sponge Cytology Using FISH — 13.3 percentage of cases among positive tests
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cytology Specimen Collection Procedure (Other); Esophagogastroduodenoscopy (Procedure); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- OHSU Knight Cancer Institute
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of Sponge Cytology Using FISH |
13.3 | — |
| PRIMARY Specificity of Sponge Cytology Using FISH |
94.7 | — |
| SECONDARY Adverse Events Associated With FISH Sponge Cytology Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
16 | — |
| SECONDARY Tolerability of FISH Spongy Cytology |
100 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 = = 30%) will be included
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02100189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.