Barrett Esophagus, Esophageal Adenocarcinoma
Conditions
Keywords
Cytosponge, GERD
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.
Interventions
DEVICECytosponge
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.
Sponsors
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participation Rate | 1 Day | Participation rate is defined as the percent of patients who agree to undergo Cytosponge testing among number of eligible patients offered Cytosponge testing. |
| Patient Tolerability Determined by Score on Likert Scale | 1 Day | 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
| Measure | Time frame | Description |
|---|---|---|
| Positive Predictive Value (PPV) | 1 Day | 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) | 1 Day | Total number of all AEs related to Cytosponge testing |
| Number of Serious Adverse Events (SAEs) | 1 Day | Total number of all SAEs related to Cytosponge testing |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cytosponge Test This arm will include individuals without formal diagnosis of Barrett's esophagus.
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. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | Cytosponge Test | — |
|---|---|---|
| Age, Continuous | 64 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 14 Participants | — |
| Sex: Female, Male Male | 37 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 2 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
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.
Time frame: 1 Day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cytosponge Test | Participation Rate | 58.6 percent of participants |
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.
Time frame: 1 Day
Population: Data was not collected due to study termination.
Secondary
Number of Adverse Events (AEs)
Total number of all AEs related to Cytosponge testing
Time frame: 1 Day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cytosponge Test | Number of Adverse Events (AEs) | 0 study-related adverse events |
Secondary
Number of Serious Adverse Events (SAEs)
Total number of all SAEs related to Cytosponge testing
Time frame: 1 Day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cytosponge Test | Number of Serious Adverse Events (SAEs) | 0 serious study-related adverse events |
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.
Time frame: 1 Day
Population: Data was not collected due to study termination.