Trial Outcomes & Findings for Rapid Assessment of Esophageal Adenocarcinoma Risk Test (NCT NCT03366012)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

1 Day

Results posted on

2024-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cytosponge Test n=51 Participants 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.
Age, Continuous	64 years n=51 Participants
Sex: Female, Male Female	14 Participants n=51 Participants
Sex: Female, Male Male	37 Participants n=51 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cytosponge Test n=51 Participants 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.
Participation Rate	58.6 percent of participants

PRIMARY outcome

Timeframe: 1 Day

Population: Data was not collected due to study termination.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Day

Population: Data was not collected due to study termination.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Day

Total number of all AEs related to Cytosponge testing

Outcome measures

Outcome measures
Measure	Cytosponge Test n=51 Participants 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.
Number of Adverse Events (AEs)	0 study-related adverse events

SECONDARY outcome

Timeframe: 1 Day

Total number of all SAEs related to Cytosponge testing

Outcome measures

Outcome measures
Measure	Cytosponge Test n=51 Participants 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.
Number of Serious Adverse Events (SAEs)	0 serious study-related adverse events

Adverse Events

Cytosponge Test

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cytosponge Test n=51 participants at risk 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.
General disorders Fever	2.0% 1/51 • 1 Day
General disorders Sore throat	2.0% 1/51 • 1 Day

Additional Information

Julian Abrams, MD, MPH

Columbia University

Phone: 212-305-1909

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place