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RecruitingInterventional

Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma

NCT ID: NCT03961945Sponsor: Mayo ClinicLast updated: 2026-01-26

Summary

This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.

Detailed description

The sponge on a string (SOS) device will be safely administered by a non-physician such as a nurse. Novel discriminant methylated DNA markers will be assayed on esophageal cytology specimens obtained from the SOS device to enable detection in Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection.

Arms & interventions

  • DeviceSponge Capsule

    Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.

Outcome measures

Primary

  • Aim 1 - Screening Population

    To measure the positive and negative predictive value of the sponge capsule Barrett's esophagus test in a screening population.

    Time frame: 5 years

  • Aim 2 - Case/Control Population BE Detection

    Compare the sensitivity and specificity of a predetermined BE prediction algorithm for those with and without GERD and assess the influence of other covariates (age, sex, ever smoking, ethnicity and BMI) on this algorithm.

    Time frame: 5 years

  • Aim 3 - Dysplasia Detection Sensitivity and Specificity

    Measure the sensitivity and specificity of a predetermined MDM panel assayed on SOS specimens from BE patients identified in Aims 1 and 2, for the detection of HGD /EAC, using surveillance histology as the criterion standard.

    Time frame: 5 years

Secondary

  • Aim 1 - Screening Population Predictive Value

    Time frame: 5 years

  • Aim 1 - Screening Population Safety and Tolerability of sponge capsule procedure

    Time frame: 5 years

  • Aim 2 - Case/Control Population Sensitivity and Specificity

    Time frame: 5 years

  • Aim 3 - Dysplasia Detection Rate of Missed Dysplasia

    Time frame: 5 years

Eligibility criteria

Sex: AllAge: 18 Years to 90 YearsHealthy volunteers: Yes
Inclusion Criteria Aim1: * Male and female ages 50-85 * Patients who have three or more risk factors for Barrett's Esophagus. * Gastroesophageal reflux disease defined by: * Diagnosis * Use of one of the following drugs \>= 3 months over the last 5 years: omeprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole, lansoprazole, ranitidine, famotidine, cimetidine * prior endoscopic diagnosis of erosive esophagitis * Body mass index (BMI) \>= 30 Exclusion Criteria Aim1 and Aim 3: * Previous history of: * esophageal adenocarcinoma/cancer * esophageal squamous carcinoma * endoscopic ablation for Barrett's esophagus * esophageal squamous dysplasia * Current treatment with oral anticoagulation including Warfarin, Coumadin * History of cirrhosis * History of esophageal/gastric varices * History of Barrett's esophagus * Prior endoscopy in the last 5 years Inclusion criteria Aim 2 and Aim 3: * Subjects with known or suspected BE (cases). * Patient between the ages 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. Exclusion criteria Aim 2: * 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. * Patients with history of esophageal resection for esophageal carcinoma. * 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 (this does not apply to the brushings/biopsies only portion of the study). * History of eosinophilic esophagitis, achalasia. * Patients on oral anticoagulation including Coumadin, Warfarin (this does not apply to the brushings/biopsies only portion of the study). * Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge 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 sponge 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.

Study locations (9)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259

Completed

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224

Completed

Mayo Clinic Health Systems - Austin

Austin, Minnesota, 55912

Recruiting
Ramona Lansing, RN · Contact
Eduardo Antpack, MD · Principal Investigator

Mayo Clinic Health Systems - Mankato

Mankato, Minnesota, 56001

Completed

Mayo Clinic Rochester

Rochester, Minnesota, 55905

Recruiting
Clinical Trials Referral Office · Contact
Ramona Lansing, R.N. · Contact
Prasad G. Iyer, M.D. · Principal Investigator

Northwell Health

New Hyde Park, New York, 11040

Completed

Baylor Scott & White Research Institute

Dallas, Texas, 75246

Completed

Mayo Clinic Health System-Eau Claire

Eau Claire, Wisconsin, 54701

Recruiting
Rebecca L. Schmidt, R.N. · Contact

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, 54601

Withdrawn