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

A vizsgálat adatai

Ki végzi

Mayo Clinic

Azonosító

NCT06071845

A regiszteradat frissítve

2026. június 2.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples for the Non-endoscopic Detection of Barrett's Esophagus With and Without Dysplasia

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.

Bevonási feltételek: Subjects with known or suspected Barrett's esophagus (BE) (cases); Patients between the ages of 18-90; Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record; Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record; Undergoing clinically indicated endoscopy; Subjects without known history of BE (controls); Undergoing clinically indicated diagnostic endoscopy.

Kizáró feltételek: For subjects with or without known evidence of BE (on history or review of medical records); Pregnant or lactating females; Patients who are unable to consent; Patients with current history of uninvestigated dysphagia; History of eosinophilic esophagitis, achalasia; Patients on oral anticoagulation including Coumadin, Warfarin; Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the Cytosponge procedure; Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the Cytosponge procedure; Patients with history of known esophageal or gastric varices or cirrhosis; Patients with history of surgical esophageal resection for esophageal carcinoma; Patients with congenital or acquired bleeding diatheses; Patients with a history of esophageal squamous dysplasia; Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment; Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.

ClinicalTrials.gov NCT06071845