Genetic markers that may show how Barrett's esophagus responds to endoscopic treatment
Studies tissue samples to find genetic markers in people with Barrett's esophagus having endoscopic treatment.
Key facts
- Who runs it
- UNC Lineberger Comprehensive Cancer Center
- Where
- Chapel Hill, United StatesSee the site
- Trial code
- Registry title
- Lucid BE Biomarkers Study
- Status
- Not yet recruiting
- People taking part
- 40 people, planned
- Starts
- Dec 2026
- Expected to end
- Feb 2034
- Type of study
- Observational
- Treatments tested
- Tissue
- Record updated
- 21 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Barrett's esophagus with abnormal cells (dysplasia) or early esophageal cancer (T1a). They must be scheduled for radiofrequency ablation or cryoablation, two treatments done through a scope that destroy the abnormal lining. Tissue samples and data will be collected.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Barrett's esophagus with low grade dysplasia (LGD) or high grade dysplasia (HGD), or T1a esophageal adenocarcinoma (EAC).
- Earlier treatment
- Must not have started any session of endoscopic eradication therapy (EET) before consent.
Main reasons for not taking part
- Barrett's esophagus without dysplasia, or where dysplasia is uncertain (indefinite)
- Treatment plan that may include endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)
- Other esophagus disease, such as Eosinophilic Esophagitis (EoE), that could disturb the test results
- Current use of blood thinners such as coumadin, warfarin, clopidogrel, heparin or low molecular weight heparin, unless stopped as required
- Known bleeding disorder, or biopsies during a scope exam not safe
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information
- Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee
- Age ≥ 18 years at the time of consent
- Scheduled to undergo radiofrequency ablation (RFA) or cryoablation of either dysplastic Barrett's Esophagus (BE with low grade dysplasia (LGD) or high grade dysplasia (HGD) or T1a esophageal adenocarcinoma (EAC)
- Have not yet initiated first session of endoscopic eradication therapy (EET1) at the time of consent
Who cannot take part
- Patients in whom the initial treatment plan includes potential for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)
- Patients with concomitant esophageal pathology such as Eosinophilic Esophagitis (EoE) which in the opinion of the investigator may produce confounding biomarker signals
- Current use of blood thinners such as coumadin, warfarin, clopidogrel, heparin and/or low molecular weight heparin (requires discontinuation of medication 5 days prior to and 6 days after esophagogastroduodenoscopy [EGD] and/or ensuring blood thinners have been stopped within an appropriate time frame for that specific agent and in accordance with standard clinical practice)
- Known bleeding disorder
- Younger than age 18 years
- Patients with non-dysplastic BE (NDBE) or are indefinite for dysplasia (IND)
- Patients who have already initiated 1 or more rounds of EET before time of consent
- Patients in which even a limited number of biopsies during Esophagogastroduodenoscopy (EGD) would be contraindicated
- Patients currently enrolled in any clinical research study involving products or interventions that, in the judgment of the investigator, could impact or interfere with this study
Where in United States
- UNC- Chapel HillChapel Hill, United StatesContact: Shilpa KaranjitNot yet recruiting
About the trial
What the trial wants to find out
The goal of this study is to learn more about genetic factors that may predict if patients with Barrett's Esophagus (BE) will respond to endoscopic treatment. Patients undergoing endoscopic eradication therapy (EET) for their BE may be eligible. After eligibility is confirmed and informed consent is complete, samples and data will be collected for use in this study.
The group in the trial
- Endoscopic Eradication Therapy (EET)
Patients undergoing radiofrequency ablation (RFA) or cryoablation of either dysplastic Barrett's Esophagus (BE with low grade dysplasia (LGD) or high grade dysplasia (HGD) or T1a esophageal adenocarcinoma (EAC).
Treatment: Tissue
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Exploratory Analysis of Biomarkers That May Signal Changes in Disease Status During Endoscopic Eradication Therapy (EET) for Barrett's Metaplasia and Neoplasia
- Plain-language title
- Genetic markers that may show how Barrett's esophagus responds to endoscopic treatmentGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 21 October 2026