Clinical Trial: Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma by a Sponge on String Device

Brief Summary: This study will evaluate if the capsule sponge device can detect the presence of Barrett's Esophagus

Detailed Summary: Assess the sensitivity and specificity of a panel of DNA methylation markers in the non-endoscopic detection of Barrett's Esophagus as well as dysplasia/carcinoma using a capsule sponge device.
Sponsor: Mayo Clinic

Current Primary Outcome: Sensitivity and specificity of Barrett's Esophagus Diagnosis [ Time Frame: 2 years. Interim analysis after 50% recruitment is complete at approximately 9 months. ]

The sensitivity and specificity of methylated DNA markers detected by the capsule sponge, in making a diagnosis of BE will be assessed using endoscopic examination as a gold standard.


Original Primary Outcome: Proportion of subjects able to swallow and extract sponge successfully (in all four sponge groups) [ Time Frame: Immediate ]

Current Secondary Outcome: Sensitivity and specificity of Barrett's dysplasia detection [ Time Frame: 2 years. Interim analysis after 50% recruitment is complete at approximately 9 months. ]

The sensitivity and specificity of methylated DNA markers detected by the capsule sponge, in making a diagnosis of BE related dysplasia will be assessed using endoscopic surveillance biopsy histology as a gold standard.


Original Secondary Outcome:

  • Mean endoscopic injury score in each of four sponge groups. [ Time Frame: 24 hours ]
    Presence and degree of mucosal abrasions scored from 1-6 (1=no evidence of trauma; 6= bleeding requiring endoscopic therapy) on endoscopic evaluation following sponge.
  • Mean DNA yield (measured in nanograms) from sponges in each of four categories. [ Time Frame: 30 days ]
    DNA will be extracted from sponges in the laboratory using standard methods


Information By: Mayo Clinic

Dates:
Date Received: September 21, 2015
Date Started: October 2015
Date Completion: June 2019
Last Updated: February 8, 2017
Last Verified: February 2017