An interventional study of Cytosponge in Barrett Esophagus and Esophageal Adenocarcinoma, sponsored by Columbia University. Terminated at 1 site in United States. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by Columbia University · Not applicable, Interventional, and Screening
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 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.
Males:
Ages 50-75 and at least one of the following:
Females:
Ages 50-75 and GERD* and at least one of the following:
Exclusion Criteria:
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.
This arm will include individuals without formal diagnosis of Barrett's esophagus.
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.
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
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
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
Number of Adverse Events (AEs)
Total number of all AEs related to Cytosponge testing
Time frame: 1 Day
Number of Serious Adverse Events (SAEs)
Total number of all SAEs related to Cytosponge testing
Time frame: 1 Day
| Milestone | Cytosponge Test |
|---|---|
| Started | 51 |
| Completed | 51 |
| Not completed | 0 |
Participation rate is defined as the percent of patients who agree to undergo Cytosponge testing among number of eligible patients offered Cytosponge testing.
| percent of participants | Cytosponge Test |
|---|---|
| Participation Rate | 58.6 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Total number of all AEs related to Cytosponge testing
| study-related adverse events | Cytosponge Test |
|---|---|
| Number of Adverse Events (AEs) | 0 |
Total number of all SAEs related to Cytosponge testing
| serious study-related adverse events | Cytosponge Test |
|---|---|
| Number of Serious Adverse Events (SAEs) | 0 |
Collected over 1 Day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cytosponge Test | 0/51 (0%) | 0/51 (0%) | 2/51 (3.9%) |
| Event | Cytosponge Test |
|---|---|
| FeverGeneral disorders | 1/51 |
| Sore throatGeneral disorders | 1/51 |
| Age, Continuous(years) | Cytosponge Test |
|---|---|
| Mean | 64 (50 to 74) |
| Sex: Female, Male(Participants) | Cytosponge Test |
|---|---|
| Female | 14 |
| Male | 37 |
| Race and Ethnicity Not Collected(Participants) | Cytosponge Test |
|---|
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Columbia University