EsoGuard for Barrett's Esophagus in Anorexia Nervosa
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate how effectively EsoGuard, a non-invasive test, can identify Barrett's esophagus in individuals with anorexia nervosa who frequently purge. The goal is to better understand the impact of long-term purging behaviors on this condition. The trial seeks participants diagnosed with an eating disorder involving purging, who have purged daily for over five years, and are admitted to a specialized center for eating disorders.
As an unphased trial, participation offers a unique opportunity to contribute to groundbreaking research that could enhance diagnosis for those with similar conditions.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that EsoGuard is likely to be safe for humans?
Research has shown that EsoGuard, a test for early signs of esophagus problems, is safe to use. In the largest real-world study of EsoGuard, results confirmed its safety. This study assessed how well people tolerated the test and found no major safety issues.
EsoGuard is a non-endoscopic test, meaning it doesn't use a scope, making it less invasive than traditional methods. This aspect reassures those concerned about discomfort or complications from more invasive procedures. Overall, evidence suggests that EsoGuard is well-tolerated and safe for detecting esophagus issues.12345Why are researchers excited about this trial?
Unlike standard treatments for Barrett's Esophagus, which often involve endoscopic procedures or medication to reduce acid reflux, EsoGuard offers a non-invasive approach. EsoGuard is a DNA test that detects changes in the esophageal cells, making it unique because it targets the condition at the molecular level. Researchers are excited about this treatment because it could allow for early detection and monitoring without the need for invasive procedures, potentially improving patient outcomes and comfort.
What evidence suggests that EsoGuard is effective for detecting Barrett's esophagus in individuals with anorexia nervosa?
Research has shown that EsoGuard, the investigational treatment in this trial, effectively detects Barrett's esophagus (BE), a condition that can lead to esophageal cancer. Studies found that individuals who tested positive with EsoGuard were 2.4 times more likely to have BE confirmed with further tests. EsoGuard also boasts a perfect negative predictive value of 100%, meaning if it indicates the absence of BE, it is very likely correct. This simple test can help identify individuals who might need more detailed procedures, such as an endoscopy. Overall, EsoGuard shows strong potential for accurately spotting early signs of esophageal cancer.36789
Who Is on the Research Team?
Allison Nitsch, MD
Principal Investigator
Denver Health and Hospital Authority
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Assessment
Non-endoscopic testing to assess the presence of Barrett's esophagus in individuals with purging behaviors
Follow-up
Participants are monitored for safety and effectiveness after assessment
What Are the Treatments Tested in This Trial?
Interventions
- EsoGuard
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
individuals with a dx of AN-BP, with a \>5-year history of purging, with a frequency of at least once a day.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Denver Health and Hospital Authority
Lead Sponsor
Lucid Diagnostics, Inc.
Industry Sponsor
Citations
Press Releases - Lucid Diagnostic Investor Relations
Patients triaged to invasive EGD following a positive non-invasive EsoGuard test had a 2.4-fold increase in the positive yield of those EGDs ...
Efficacy of EsoGuard Assay on Esophageal Surface Cells ...
The primary efficacy objectives of this study are to measure the sensitivities of EsoGuard-based diagnosis in 54 cases each of non-dysplastic Barrett's ...
3.
targetedonc.com
targetedonc.com/view/esoguard-be-1-trial-validates-effective-screening-for-esophageal-precancerEsoGuard BE-1 Trial Validates Effective Screening ...
EsoGuard demonstrated promise in the detection of esophageal precancer (Barrett's Esophagus; BE) and esophageal adenocarcinoma (EAC), ...
Enhancing the Diagnostic Yield of EGD for Diagnosis of ...
EG triage enriches the population undergoing EGD for BE detection. Compared with screening EGD alone, it improves diagnostic yield.
NCI-Sponsored Study Shows Positive Data for Lucid ...
EsoGuard demonstrated excellent negative predictive value (NPV) of 100% for detecting esophageal precancer, consistent with its unprecedented ...
Press Releases - Lucid Diagnostic Investor Relations
The study authors concluded that "the largest real-world experience of EsoGuard and EsoCheck to date" demonstrates "excellent safety, ...
Use of the EsoGuard® Molecular Biomarker Test in Non- ...
Levine, D.S., et al., An endoscopic biopsy protocol can differentiate high-grade dysplasia from early adenocarcinoma in Barrett's esophagus.
Nonendoscopic Testing for Esophageal Precancer in an At ...
For disease surveillance in the future, it would be ideal if a nonendoscopic screening test such as EsoGuard could be used with a test like TissueCypher to risk ...
Lucid Diagnostics' ESOGUARD BE-1 Prospective Multicenter ...
EsoGuard sensitivity and negative predictive value for detecting BE were approximately 88% and 99%, respectively. Specificity and positive ...
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