Rapid Assessment of Esophageal Adenocarcinoma Risk Test

Barrett Esophagus Clinical Trial

— REACT  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03366012
• Other study ID #: AAAR5884
• Status: Suspended
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The incidence of esophageal adenocarcinoma (EAC) has risen over the past half century and continues to have a dismal prognosis. Even though it has been established that Barrett's esophagus (BE) is the precursor lesion to EAC, more than 90% of EAC patients are never diagnosed with BE beforehand. Thus, the opportunity is missed to identify most patients at high risk for EAC who could benefit from surveillance and early endoscopic therapy, which in turn may lower EAC mortality. Upper endoscopy is the only means to diagnose BE, yet widespread endoscopic screening is impractical and expensive. There is an urgent need to develop minimally-invasive methods of BE screening that can be easily performed in the primary care setting to allow for efficient and cost-effective interventions to decrease EAC mortality.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

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)

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Esophageal Adenocarcinoma
• Esophageal Neoplasms

Intervention

Device:
• Cytosponge
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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participate Rate	Participation rate is defined as the proportion of patients who agree to undergo Cytosponge testing among number of eligible patients offered Cytosponge testing.	1 Day
Primary	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	Positive Predictive Value (PPV)	The PPV is the proportion of patients with endoscopic and histologic evidence of Barrett's esophagus on upper endoscopy from the total number of patients with TFF3-positive Cytosponge test who undergo a follow up endoscopy.	1 Day
Secondary	Number of Adverse Events (AEs)	Total number of all AEs related to Cytosponge testing	1 Day
Secondary	Number of Serious Adverse Events (SAEs)	Total number of all SAEs related to Cytosponge testing	1 Day