Clinical trial: Esophageal Cytology With FISH in Detecting Esophageal Cancer (NCT02100189)

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 =< 3
             (Karnofsky >= 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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough.  Her other medical problems include hypertension, dyslipidemia, and osteoarthritis.  She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg.  The patient's breath smells bad. Other physical examinations are normal.  A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus.

Patient description (patient's own words): I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus.

Does the patient match the trial criteria? 1