The Acceptability of a Rapid Esophageal Adenocarcinoma Risk Test (REACT)

Contact:

NCT Number:

Protocol:

AAAR5884

Study Status:

Closed to Accrual, Study Active

Population:

Adult

Phase:

NA

This study aims to evaluate the acceptability of a new non-invasive screening device to test for Barrett's esophagus. The investigators will prospectively enroll 100 patients to undergo Cytosponge testing. The time of involvement for an individual will range from 2 weeks to 2 months, depending on the results of the Cytosponge test and time to follow up endoscopy, if indicated. The Cytosponge consists of a 3cm diameter, polyester, medical grade spherical sponge on a string, compressed within a gelatin capsule. The capsule is swallowed while the patient or the research specialist holds onto the string. After 5 minutes, the gelatin capsule dissolves allowing the spherical sponge to expand. The sponge is then retrieved by gently pulling on the string, thus collecting cells along the passageway through the entire length of the esophagus. The sample is then put into a preservative to be processed for immunohistochemical testing for trefoil factor 3 (TFF3) to determine diagnosis of Barrett's esophagus.

Are you Eligible? (Inclusion Criteria)

  • Males: Ages 50-75, and at least ONE of the following:
  • Gastroesophageal reflux disease (GERD)
  • Current reflux medication use (PPI or H2RA)
  • Family history (first degree relative) with Barrett's esophagus or esophageal adenocarcinoma
  • Both body mass index (BMI) ≥30
  • A history of cigarette smoking Females: Ages 50-75, and Gastroesophageal reflux disease (GERD) or reflux medication use(PPI or H2RA) and at least ONE of the following:
  • Family history (first degree relative) with Barrett's esophagus or esophageal adenocarcinoma
  • BMI ≥30
  • A history of cigarette smoking

Specialty Area(s)

Esophageal Cancer, Barrett's Esophagus

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032