Trans-Oral Sampling as an alternative for Barrett Surveillance: Transitioning Across Different Sampling Modalities through Cross-Validation; .

Trans-Oral Sampling as an alternative for Barrett Surveillance: Transitioning Across Different Sampling Modalities through Cross-Validation; . - The TOSS Transition study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57125

Enrollment

230

Registered

2024-06-20

Start date

2024-11-25

Completion date

Unknown

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett Esophagus Dysplasia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients age: >= 18 years - BE with a maximal extent of >=1cm - Willingness to undergo an esophagogastroduodenoscopy (EGD) with sampling using a pill-on-a-string device. - Willingness to undergo an trans oral sampling procedure with a pill on the string device - Cohort 1: Barrett's Esophagus (BE) patients who, within 18 months before or during the baseline endoscopy, have the worst grade pathology diagnosis of High-Grade Dysplasia (HGD) or Esophageal Adenocarcinoma (EAC), or present a visible lesion suspected of neoplasia. - Cohort 2: Barrett's Esophagus (BE) patients who, within 18 months before or during the baseline endoscopy, have the worst grade pathology diagnosis of Low-Grade Dysplasia (LGD). - Cohort 3: Barrett's Esophagus (BE) patients who, within 18 months before or during the baseline endoscopy, show no evidence of dysplasia - Ability to give written, informed consent and understand the responsibilities of participation

Exclusion criteria

Exclusion criteria: • History of esophageal or gastric surgery other than fundoplication • History of endoscopic treatment for neoplasia in the esophagus or stomach. • History of esophageal ablation or dilation therapy  • Presence of esophageal varices and/or suspected portal hypertension during  imaging endoscopy at baseline • Present Dysphagia/ swallowing disorders at the time of screening and  participation • 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

Design outcomes

Primary

Measure	Time frame
To compare the diagnostic accuracy (sensitivity and specificity) of genetic markers in detecting at-risk patients (defined as having a diagnosis of LGD, HGD, or EAC) across three sampling modalities: biopsy, brush sampling, and TOS*	—

Secondary

Measure	Time frame
2 To compare the diagnostic accuracy (sensitivity and specificity) of genetic markers in detecting high-risk patients (defined as having a diagnosis HGD or EAC) across three sampling modalities: biopsy, brush sampling, and TOS 3 The number and type of genetic markers uniquely detected by each sampling method and their relative abundance or detection rate in each method. 4. The spatial distribution patterns and detection rates of progression-associated genetic markers in biopsy, brush sampling, and TOS samples.	—

Measure

Time frame

2 To compare the diagnostic accuracy (sensitivity and specificity) of genetic markers in detecting high-risk patients (defined as having a diagnosis HGD or EAC) across three sampling modalities: biopsy, brush sampling, and TOS 3 The number and type of genetic markers uniquely detected by each sampling method and their relative abundance or detection rate in each method. 4. The spatial distribution patterns and detection rates of progression-associated genetic markers in biopsy, brush sampling, and TOS samples.

—

Countries

Belgium, Netherlands

Contacts

Public ContactD. Wajon

Amsterdam UMC

d.wajon@amsterdamumc.nl0625716051

Outcome results