Gastroesophageal Reflux Disease Clinical Trial
Official title:
Next Generation Sequencing of Esophageal Cytology for the Early Detection of Esophageal Cancer
Verified date | November 2020 |
Source | OHSU Knight Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot clinical trial studies how well a swallowable sponge cell sampling device and next generation sequencing work in detecting esophageal cancer in patients with low or high grade dysplasia, Barrett esophagus, or gastroesophageal reflux disease. Checking biomarkers in abnormal esophageal cells using a swallowable sponge cell sampling device and next generation sequencing may improve diagnosis and treatment of esophageal cancer.
Status | Completed |
Enrollment | 11 |
Est. completion date | October 10, 2017 |
Est. primary completion date | October 10, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Ability to understand and the willingness to sign a written informed consent document - Patients must be scheduled for a procedure capable of providing a definitive pathologic diagnosis and evaluating for complications of the esophageal sponge on the same day as the study procedure, either upper endoscopy or surgical esophagectomy - One of the following inclusion criteria must be true for patient to be eligible for enrollment: - Subjects with known esophageal cancer (adenocarcinoma or squamous cell carcinoma) - Subjects with a history of low or high grade dysplasia - Subjects with risk factors for esophageal malignancy including Barrett?s esophagus and gastroesophageal reflux disease (GERD) Exclusion Criteria: - Subjects that are unable to swallow a tablet/pill - Subjects with completely obstructing esophageal cancer - Subjects with known or suspected esophageal varices - 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 - Any condition which, in the opinion of the investigator precludes the patient from completion of the study procedure |
Country | Name | City | State |
---|---|---|---|
United States | OHSU Knight Cancer Institute | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
OHSU Knight Cancer Institute | Oregon Health and Science University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detection of gene mutations using next generation sequencing (NGS) | Will calculate the concordance of the gene mutations identified from the sponge sample to those identified from the tissue biopsy (control). | Up to 2 years | |
Secondary | Sensitivity and specificity of the NGS probes to detect underlying esophageal dysplasia or cancer | Up to 2 years |
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