Rapid Assessment of Esophageal Adenocarcinoma Risk Test

NCT03366012 | Terminated Results DMC FDA Device

• 1 other identifier: AAAR5884
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Barrett Esophagus; Esophageal Adenocarcinoma

Keywords

Cytosponge; GERD

Outcome Measures

Primary Outcomes (2)

• Participation Rate

  Participation rate is defined as the percent of patients who agree to undergo Cytosponge testing among number of eligible patients offered Cytosponge testing.

  1 Day

• Patient Tolerability Determined by Score on Likert Scale

  After undergoing the Cytosponge test, subjects will be asked to take a "Cytosponge Post-Procedure Questionnaire" to assess tolerability using a Likert scale from 1 (no discomfort) to 10 (severe discomfort) and whether they would be willing to undergo Cytosponge testing again (yes/no). The scale for each question is rated 1 to 10. Lower scores are "better" (greater tolerability for that particular measure), higher scores are "worse" (less tolerable for that particular measure). Each question on the questionnaire will be assessed independently (i.e. one score per question). No total scores are calculated.

  1 Day

Secondary Outcomes (3)

• Positive Predictive Value (PPV)

  1 Day

• Number of Adverse Events (AEs)

  1 Day

• Number of Serious Adverse Events (SAEs)

  1 Day

Study Arms (1)

Cytosponge Test

OTHER

This arm will include individuals without formal diagnosis of Barrett's esophagus.

Device: Cytosponge

Interventions

Cytosponge DEVICE

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 3-5 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.

Cytosponge Test

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males:
• Ages 50-75 and at least one of the following:
• Gastro-esophageal reflux disease (GERD)\* or
• Family history (first degree relative) with Barrett's esophagus or esophageal adenocarcinoma or
• Both body mass index (BMI) ≥30 or
• A history of cigarette smoking (at least 10 pack years)
• Females:
• Ages 50-75 and GERD\* and at least one of the following:
• Family history (first degree relative) with Barrett's esophagus or esophageal adenocarcinoma or
• BMI ≥30 or
• A history of cigarette smoking (at least 10 pack years)

You may not qualify if:

• History of gastric or esophageal cancer
• History of esophageal surgery
• Known untreated esophageal stricture or uninvestigated dysphagia
• Previous upper endoscopy within 10 years
• Cancer within 3 years except for non-melanoma skin cancer
• Portal hypertension, with or without known varices
• Uncontrolled coagulopathy
• Uncontrolled major comorbid illness
• Inability to tolerate or contraindication to upper endoscopy
• Inability to give informed consent
• GERD defined as either a history of frequent heartburn or fluid regurgitation symptoms (at least weekly for 6 months) or regular use of proton pump inhibitors or histamine-2 receptor antagonists.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders

Results Point of Contact

• Title: Julian Abrams, MD, MPH
• Organization: Columbia University

ja660@cumc.columbia.edu

212-305-1909

Study Officials

• Julian Abrams, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 8, 2017
• Study Start: August 1, 2018
• Primary Completion: May 19, 2023
• Study Completion: May 19, 2023
• Last Updated: November 8, 2024
• Results First Posted: November 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)