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Minimally Invasive Screening Tool for the Diagnosis of Barrett’s Esophagus and Esophageal Cancer
Trial Status: active
This phase IIb trial tests whether a minimally invasive screening tool, sponge on a string device, works to diagnose Barrett’s esophagus and esophageal cancer in patients with or without Barrett’s esophagus or chronic gastroesophageal reflux disease. There is currently an absence of a minimally invasive tool for the detection of Barrett’s esophagus, which has led to the recommendations for Barrett's screening being limited to those with chronic gastroesophageal reflux disease, even though 50% of those with Barrett's and esophageal adenocarcinoma do not endorse symptoms of chronic reflux. The sponge on a string device may help researcher obtain specimens that can be analyzed in a lab as a less invasive way to check Barrett’s esophagus and esophageal cancer.
Inclusion Criteria
AIM I: All participants will be 50 years of age or older and 85 years of age or younger
AIM I: With or without gastroesophageal reflux disease (defined as symptoms of heartburn or acid regurgitation more than once a week or taking proton pump inhibitors for more than 3 months, or those with the diagnosis of gastroesophageal reflux disease in the diagnostic index, or those with endoscopic evidence of esophagitis)
AIM I: Other risk factors considered would include: Caucasian race, history of ever smoking (current or prior history of smoking), body mass index (BMI) greater than or equal to 30, family history of Barrett's esophagus or esophageal adenocarcinoma and male sex
AIM II: Subjects with known or suspected Barrett's esophagus (BE) (cases)
* Patient between the ages 18 - 90
* Patients with a BE segment >= 1 cm in maximal extent endoscopically
* Histology showing evidence of intestinal metaplasia with or without presence of dysplasia
* Undergoing clinically indicated endoscopy
AIM II: Subjects without known history of BE (controls)
* Undergoing clinically indicated diagnostic endoscopy
Exclusion Criteria
AIM I: History of Barrett's esophagus or esophageal adenocarcinoma
AIM I: Prior endoscopy in the last 5 years
AIM I: Pregnant or lactating females
AIM I: Patients who are unable to consent
AIM I: Patients with current history of uninvestigated dysphagia
AIM I: History of eosinophilic esophagitis, achalasia
AIM I: Patients on oral anticoagulation including Coumadin, Warfarin
AIM I: Patients on antiplatelet agents including Clopidogrel (visit 1), unless discontinued for three to five days prior to the sponge procedure (visit 2, 2A, and 3)
AIM I: Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban (visit 1), unless discontinued for three to five days prior to the sponge procedure (visit 2, 2A, and 3)
AIM I: Patients with history of known esophageal/gastric varices or cirrhosis
AIM I: Patients with history of esophageal resection due to carcinoma
AIM I: Patients with congenital or acquired bleeding diatheses
AIM I: Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma
AIM I: Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment
AIM I: Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer
AIM II SUBJECTS WITH KNOWN BE: Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection (EMR)/endoscopic submucosal dissection (ESD) alone will not be excluded
AIM II SUBJECTS WITH KNOWN BE: Patients with history of esophageal resection for esophageal carcinoma
AIM II: Pregnant or lactating females
AIM II: Patients who are unable to consent
AIM II: Patients with current history of uninvestigated dysphagia (this does not apply to the brushings only portion of the study)
AIM II: History of eosinophilic esophagitis, achalasia
AIM II: Patients on oral anticoagulation including Coumadin, Warfarin
AIM II: Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge procedure
AIM II: 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 sponge procedure
AIM II: Patients with history of known esophageal or gastric varices or cirrhosis
AIM II: Patients with history of esophageal or gastric resection
AIM II: Patients with congenital or acquired bleeding diatheses
AIM II: Patients with a history of esophageal squamous dysplasia
AIM II: Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment
AIM II: Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03961945.
I. To measure the positive and negative predictive value of the sponge on a string (SOS) Barrett's esophagus test in a screening population.
II. To identify factors influencing specificity of SOS sampled methylated deoxyribonucleic acid (DNA) markers for Barrett's esophagus diagnosis.
III. To measure the accuracy of methylated DNA marker candidate’s prevalent dysplasia/adenocarcinoma in Barrett's esophagus cases.
OUTLINE:
Participants undergo the SOS BE test over 5-10 minutes at baseline. Participants also undergo an upper endoscopy over 10-20 minutes. Patients may undergo a second SOS BE test if endoscopy is diagnostic for BE.
