Trans-Oral Sampling as an Alternative Surveillance of Barrett's Esophagus Pilot (TOSS pilot)

Trans-Oral Sampling as an Alternative Surveillance of Barrett's Esophagus Pilot: TOSS Pilot Study

The study aims to address the increasing incidence of esophageal cancer and Barrett's esophagus (BE) in the Western world by exploring a more efficient surveillance method. Esophageal adenocarcinoma (EAC) has a poor prognosis if diagnosed late, emphasizing the need for early detection strategies. Current surveillance methods, involving regular endoscopies, are burdensome and costly, particularly for low-risk patients. The study investigates the potential of the Endosign, a Trans Oral Sampling (TOS) device, as an alternative to endoscopic surveillance. The objective is to determine if Endosign can provide sufficient quality samples, containing columnar cells and clot preparations at least 5mm in size, thus offering a reliable substitute for endoscopic sampling. The study includes non-dysplastic and dysplastic BE patients undergoing surveillance or treatment and employs a single-center, prospective feasibility approach.

Study Overview

• Status: Active, not recruiting
• Conditions: Barrett Esophagus; Esophageal Adenocarcinoma; Diagnosis
• Intervention / Treatment: Diagnostic test: trans oral sampling: endosign

Detailed Description

Esophageal adenocarcinoma (EAC) has a poor prognosis when diagnosed at an advanced stage. Yet when EAC is identified at an early stage, patients can be treated endoscopically, reducing mortality and morbidity. However, the early detection currently relies on endoscopic surveillance, since there is no proper alternative.

Barrett's esophagus is the precursor lesion to EAC. Currently, all patients with Barrett's esophagus (BE) will undergo several esophagogastroduodenoscopies (EGD) in their lifetime compliant with the surveillance strategy for early cancer detection. However, the annual risk of high-grade dysplasia (HGD) or EAC for the Barrett's surveillance population is less than 1 percent. An assessment of the prevalence of EAC and BE by age group using data from more than 5 million people showed that the relative number of Barrett patients has increased substantially. This increase is not based on enhanced screening, but with the recent rise of better available screening tools, the number of patients diagnosed with BE is also expected to increase in the coming years. Both culminating in a high-volume surveillance population.

A cost-effectiveness analysis showed that for most patients with a low risk of developing EAC, it is not cost-effective to continue with the current surveillance strategy that requires patients to come back for endoscopy after a fixed interval. In addition to the costs associated with endoscopy, patients suffer anxiety and distress before their surveillance endoscopy. BE patients have a worse quality of life due to the overestimation of their risk of cancer. Patients should receive a surveillance strategy more aligned with their risk profile. But since there is not an adequate substitute for endoscopic surveillance, the current strategy is being continued. To relieve low risk-patients and ensure adequate utilization of health care resources, there is a need for a reliable alternative.

The Endosign, a sample collection device in class I , is a well-investigated transoral sampling device that can be administered easily and safely. Studies have been performed investigating the Endosign, a sample collection device in class I, for screening purposes. The tissue collected with the inexpensive tool showed to be well assessable for identifying BE patients. Transoral sampling is well-tolerated by patients. The device has shown great efficacy and cost-effectiveness. Nevertheless, the potential use for surveillance and risk stratification remains unclear.

The aim of this study is to investigate whether the tissue collected by the Endosign could be utilized in the detection of early cancer and identification of patients at increased risk of neoplastic progression. With good quality sampling using the Endosign, transoral sampling could be the alternative for endoscopic surveillance of Barrett's esophagus.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• Netherlands
  • North Holland
    • Amsterdam, North Holland, Netherlands, 1081HV
      • Amsterdam University Medical Centre, loc. VUmc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

: non dysplastic and dysplastic BE patients who will undergo endoscopy for surveillance or treatment

Description

Inclusion Criteria:

• - Patients age: ≥ 18 years
• BE with a maximal extent of ≥4cm
• Willingness to undergo an esophagogastroduodenoscopy with sedation
• Cohort 1: Patients referred for endoscopic treatment of HGD or EAC
• Cohort 2: Patients with known BE without a diagnosis of HGD or EAC in the previous 18 months, undergoing endoscopic surveillance
• Ability to give written, informed consent and understand the responsibilities of participation

Exclusion Criteria:

• Patients within eight weeks after endoscopy with biopsies and/or ER
• History of esophageal or gastric surgery other than Nissen fundoplication
• History of esophageal ablation or dilation therapy
• Presence of esophageal varices and/or suspected portal hypertension
• Dysphagia/ swallowing disorders
• Pregnancy
• Patients with known or suspected anatomical abnormalities of the esophagus or stomach
• Patients taking anti-thrombotic drugs that cannot be temporarily discontinued
• Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohor 1: 30 BE patients referred for an endoscopic treatment of HGD or EAC.	Diagnostic test: trans oral sampling: endosign; the endosign samples the esophagus by pulling the string on a sponge
cohort 2; 30 patients under standard BE surveillance without a diagnosis of HGD or EAC in previous 18 months	Diagnostic test: trans oral sampling: endosign; the endosign samples the esophagus by pulling the string on a sponge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to determine the number of sufficient quality samples obtained through the use of the Endosign, which could potentially serve as a substitute for endoscopic sampling.	The amount of samples collected with the Endosign that contain columnar cells and are processed to clot preparations that are at least 5mm in size.	1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the practicability of the trans oral sample procedure	2 The number of successful Endosign study procedures. A successful Endosign procedure is defined as the retrieval of the specimen as intended and its preservation in a manner that makes it usable for processing making it a clot preparation of at least 5 mm in size.	1 year
Concordance of dysplasia detection between capsule sponge and standard endoscopic biopsy	Presence or absence of dysplasia detected by capsule sponge and standard endoscopic biopsy in the same participant, with paired comparison analyzed using McNemar's test	1 year
Concordance of intestinal metaplasia detection	Presence or absence of intestinal metaplasia detected by capsule sponge and standard endoscopic biopsy in the same participant, with paired comparison analyzed using McNemar's test	1 year
Intraobserver agreement for histologic findings in Capsule Sponge Samples	Intraobserver agreement for histologic classification in capsule sponge samples, based on repeated assessment of the different Capsulesponge samples taken at baseline sampling, reported as Cohen's kappa coefficient	1 year
Intraobserver agreement of genomic markers	Intraobserver agreement for genomic marker detection in capsule sponge samples, based on repeated analysis of the same capsule sponge samples obtained at baseline, reported as Cohen's kappa coefficient for categorical variables and intraclass correlation coefficient (ICC) for continuous variables	1 year

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2023
• Primary Completion (Estimated): April 20, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Feasibility; surveillance; dysplasia; detection; Esophageal Adenocarcinoma; barretts esophagus
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Pathological Conditions, Signs and Symptoms; Disease; Barrett Esophagus; Adenocarcinoma Of Esophagus
• Other Study ID Numbers: NL84099.018.23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No