Researchers aim to detect esophageal precancer with state-of-the-art medical technologies

Researchers at Case Western Reserve University (CWRU) and University Hospitals (UH) will use state-of-the-art medical technologies they invented-and licensed to Lucid Diagnostics Inc.-to detect esophageal precancer, specifically Barrett's Esophagus (BE).

BE is a change in the cellular structure of the esophageal lining typically caused by gastroesophageal reflux disease (GERD), also known as heartburn. The goal is to reduce the incidence of esophageal cancer (EAC).

EAC is a rare type of cancer with a high-morality rate-the cause of 2.6% of all cancer deaths nationally-and is more common in men than women, according to the National Cancer Institute. Given that esophageal cancer has a stark 20%, five-year survival rate, early detection and treatment of BE are critical to reducing EAC-related mortality.

Case Western Reserve and UH will evaluate how effective EsoCheck and EsoGuard-two FDA-approved technologies developed by Lucid Diagnostics-are in detecting BE in a non-GERD population that meets the American Gastroenterological Association's (AGA) criteria for screening.

Patients without GERD symptoms account for nearly half of prevalent EAC cases. However, these individuals are excluded from the American College of Gastroenterology (ACG) guidelines where chronic GERD is a mandatory prerequisite for screening. We aim to utilize EsoCheck and EsoGuard to improve BE detection within an at-risk population that would otherwise go unscreened, and to do so in a manner that does not over-tax limited endoscopy resources."

Amitabh Chak, professor of medicine and oncology at CWRU, gastroenterologist at UH and the Brenda and Marshall B. Brown Master Clinician in Innovation and Discovery at UH Seidman Cancer Center

The clinical trial will involve 800 participants recruited from UH, University of Colorado, Johns Hopkins University, University of North Carolina and Cleveland Clinic.

The research is supported with a new five-year, $8 million grant from the National Institutes of Health.

"This award is a wonderful recognition and the culmination of the esophageal cancer prevention work our team has been aggressively working on for the last 10 years," said Sanford Markowitz, the study's principal investigator and the Ingalls Professor of Cancer Genetics at the Case Western Reserve School of Medicine. "We are truly excited at the chance of advancing these potentially life-saving technologies, which could increase the number of people who qualify for esophageal precancer screening and provide fresh hope for esophageal cancer prevention."

Markowitz, Chak, Joseph Willis, a professor in the Department of Pathology, and Helen Moinova, an instructor at the School of Medicine are all inventors of the technologies and strategic advisors to Lucid Diagnostics.

To close the gap and lessen the strain on limited endoscopic resources, the research team will use EsoCheck and EsoGuard to identify BE in at-risk adults who would not otherwise be tested.

Clinicians can quickly and non-invasively gather surface esophagus cells for analysis without endoscopy by using the EsoCheck technology. The EsoCheck capsule, which resembles a gel cap and is connected to a thin catheter, is swallowed by patients.

Following cell retrieval, the EsoGuard DNA test is used to identify abnormal esophageal cells and diagnose disease before it progresses.