Back to resultsRapid Assessment of Esophageal Adenocarcinoma Risk Test (REACT)
Primary Purpose
Barrett Esophagus, Esophageal Adenocarcinoma
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cytosponge
Sponsored by
About this trial
This is an interventional screening trial for Barrett Esophagus focused on measuring Cytosponge, GERD
Eligibility Criteria
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.
Sites / Locations
- Columbia University Irving Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cytosponge Test
Arm Description
This arm will include individuals without formal diagnosis of Barrett's esophagus.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Number of Adverse Events (AEs)
Total number of all AEs related to Cytosponge testing
Number of Serious Adverse Events (SAEs)
Total number of all SAEs related to Cytosponge testing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03366012
Brief Title
Rapid Assessment of Esophageal Adenocarcinoma Risk Test
Acronym
REACT
Official Title
The Acceptability of a Rapid Assessment of Esophageal Adenocarcinoma Risk Test (REACT)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why Stopped
Product recall
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus, Esophageal Adenocarcinoma
Keywords
Cytosponge, GERD
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cytosponge Test
Arm Type
Other
Arm Description
This arm will include individuals without formal diagnosis of Barrett's esophagus.
Intervention Type
Device
Intervention Name(s)
Cytosponge
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participate Rate
Description
Participation rate is defined as the proportion of patients who agree to undergo Cytosponge testing among number of eligible patients offered Cytosponge testing.
Time Frame
1 Day
Title
Patient Tolerability determined by Score on Likert Scale
Description
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.
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Positive Predictive Value (PPV)
Description
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.
Time Frame
1 Day
Title
Number of Adverse Events (AEs)
Description
Total number of all AEs related to Cytosponge testing
Time Frame
1 Day
Title
Number of Serious Adverse Events (SAEs)
Description
Total number of all SAEs related to Cytosponge testing
Time Frame
1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian Abrams, MD, MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Rapid Assessment of Esophageal Adenocarcinoma Risk Test
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