Assessment of a Minimally Invasive Collection Device for Molecular

Status Recruiting

Clinical Trial Summary

This clinical trial evaluates the use of cytosponge, a minimally invasive collection device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy. Non-endoscopic swallowable encapsulate sponge cell collection devices combined with markers for BE/esophageal adenocarcinoma (EAC) detection are a guideline-endorsed alternative to endoscopy for BE screening. The Oncoguard registered trademark Esophagus test (OGE) test uses esophageal cytology specimens collected with a minimally invasive, non-endoscopic, encapsulated sponge sampling device to identify BE/EAC biomarkers that indicate whether a patient should undergo diagnostic endoscopy. The OGE test is a simple and cost effective screening method that may lower barriers to widespread adoption of BE screening in at risk patients, resulting in increased and earlier detection of BE/EAC.

Clinical Trial Description

PRIMARY OBJECTIVES: I. Measure Deoxyribonucleic acid (DNA) yield from esophageal cytology samples collected with the Cytosponge device. II. Evaluate the methylated DNA markers (MDM) levels and accuracy of the Oncoguard Esophagus test (OGE test) for the detection of methylated DNA markers in Cytosponge collected esophageal cytology samples. SECONDARY OBJECTIVES: I. Assess the tolerability of the Cytosponge device using a tolerability questionnaire II. Evaluate presence of any trauma to the esophagus from the passage of the Cytosponge device using the endoscopic injury score. OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients with known or suspected Barrett's Esophagus undergo a biopsy and sample collection with the cytosponge followed by standard of care endoscopy and complete surveys while on study. ARM II: Patients without known or suspected Barrett's Esophagus undergo a biopsy and sample collection with the cytosponge followed by standard of care endoscopy and complete surveys while on study. ;

Study Design

Related Conditions & MeSH terms

Barrett Esophagus
Barrett's Esophagus Without Dysplasia
Barretts Esophagus With Dysplasia
Esophageal Adenocarcinoma
Hyperplasia

Clinical Trial Details

NCT number	NCT06071845
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Recruiting
Phase	N/A
Start date	October 16, 2023
Completion date	December 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03554356` - Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE)	N/A
Completed	`NCT03015389` - Wide Area Transepithelial Sample Esophageal Biopsy Combined With Computer Assisted 3-Dimensional Tissue Analysis (WATS3D) For the Detection of High Grade Esophageal Dysplasia and Adenocarcinoma
Completed	`NCT03434834` - OCT Pilot in Esophagus	N/A
Terminated	`NCT04642690` - Nitrates and IL-8 in Barrett's Esophagus
Completed	`NCT03468634` - Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy	N/A
Recruiting	`NCT02310230` - An Evaluation of the Utility of the ExSpiron Respiratory Variation Monitor During Upper GI Endoscopy	N/A
Completed	`NCT00217087` - Endoscopic Therapy of Early Cancer in Barretts Esophagus	Phase 2
Completed	`NCT02284802` - Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy	N/A
Recruiting	`NCT05530343` - Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance	N/A
Active, not recruiting	`NCT04151524` - Classification of Adenocarcinoma of the Esophagogastric Junction
Completed	`NCT00955019` - Novel Method of Surveillance in Barrett's Esophagus	Phase 2
Terminated	`NCT00386594` - Pilot Study of Oral 852A for Elimination of High-Grade Dysplasia in Barrett's Esophagus	N/A
Completed	`NCT00576498` - Novel Imaging Techniques in Barrett's Esophagus	N/A
Completed	`NCT02688114` - Healing of the Esophageal Mucosa After RFA of Barrett's Esophagus	N/A
Completed	`NCT02560623` - A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus	N/A
Recruiting	`NCT05056051` - Wide-Area Transepithelial Sampling in Endoscopic Eradication Therapy for Barrett's Esophagus	N/A
Recruiting	`NCT04001478` - Non-invasive Testing for Early oEesophageal Cancer and Dysplasia
Completed	`NCT03859557` - The Evaluation of Patients With Esophageal and Foregut Disorders With WATS (Wide Area Transepithelial Sample With 3-Dimensional Computer-Assisted Analysis) vs. 4-Quadrant Forceps Biopsy
Completed	`NCT04587310` - Does Laparoscopic Sleeve Gastrectomy Lead to Barrett's Esophagus, 5-year Esophagogastroduodenoscopy Findings: A Retrospective Cohort Study
Recruiting	`NCT05107219` - GCC Agonist Signal in the Small Intestine	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples — SOS4C

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms