Barrett's EsophagusNCT07887568
Lucid BE Biomarkers Study
An observational study of Barrett's Esophagus and Barrett's Esophagus With Dysplasia, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus, Barrett's Esophagus With Dysplasia, Esophageal Adenocarcinoma (EAC)
- What is being tested?
- Tissue
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Feb 2034
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing endoscopic eradication therapy (EET) - 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) as part of their routine clinical care.
Who may be able to join
- 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 join
- Younger than age 18 years
- Patients with non-dysplastic BE (NDBE) or are indefinite for dysplasia (IND).
- Patients in whom the initial treatment plan includes potential for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD).
- Patients who have already initiated 1 or more rounds of EET before time of consent.
- Patients with concomitant esophageal pathology such as Eosinophilic Esophagitis (EoE) which in the opinion of the investigator may produce confounding biomarker signals.
- Patients in which even a limited number of biopsies during Esophagogastroduodenoscopy (EGD) would be contraindicated.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
Shilpa Karanjit, 919-843-8519, shilpa_karanjit@med.unc.edu
Nicholas Shaheen, MD, MPH
About this study
Official title: Exploratory Analysis of Biomarkers That May Signal Changes in Disease Status During Endoscopic Eradication Therapy (EET) for Barrett's Metaplasia and Neoplasia
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.
Read the detailed description
This is a single-site study designed to explore genetic and epigenetic changes in patients with Barrett's esophagus (BE), a condition in which the lining of the esophagus changes and may develop into cancer. The study will include patients with dysplasia (abnormal cell changes) or neoplasia (abnormal tissue growth that may be precancerous or cancerous) who are undergoing endoscopic eradication therapy (EET), a treatment that uses an endoscope (a thin, flexible tube with a camera) to remove or destroy abnormal tissue.
The study will examine genetic changes, such as copy number alterations (changes in the number of copies of specific sections of DNA) and mutations (changes in the DNA sequence), as well as epigenetic changes, such as abnormal DNA methylation (chemical changes that can affect how genes work without changing the DNA sequence). The investigators will assess whether the disappearance or persistence of specific molecular markers associated with the development of abnormal tissue and cancer in Barrett's esophagus can help predict treatment success or failure and the return of precancerous or cancerous tissue after treatment.
Eligible participants undergoing endoscopic eradication therapy will be enrolled in the study. Relevant medical information and biological samples will be collected during endoscopic procedures performed as part of routine clinical care and analyzed for the study. This single-site study is intended to generate preliminary findings to guide future research.
- Being tested
- Tissue
- Keywords
- Barrett's Esophagus
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TissueOther
Tissue collection during each endoscopic eradication therapy session.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic changes
Genetic changes, including copy number alterations and gene mutations, in biopsy samples from patients with Barrett's esophagus and dysplasia or neoplasia undergoing endoscopic eradication therapy (EET) will be documented.
Measured: Baseline, up to 5 years
Secondary outcomes (1)
Epigenetic changes
Epigenetic changes such as aberrant DNA methylation in patients with Barrett's esophagus (BE) and either dysplasia or neoplasia undergoing endoscopic eradication therapy (EET), within the biopsy taken will be documented.
Measured: Baseline, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionAug 2033 (estimated)
- Study completionFeb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lucid Diagnostics, Inc.
- Responsible party
- Sponsor
- Investigators
- Nicholas Shaheen, MD, MPH, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887568
- Sponsor's protocol ID
- LCCC2620
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Analysis of Biomarkers That May Signal Changes in Disease Status During Endoscopic Eradication Therapy (EET) for Barrett's Metaplasia and Neoplasia
- ClinicalTrials.gov ID
- NCT07887568
- Acronym / sponsor ID
- LCCC2620
- Keywords
- Barrett's Esophagus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Lucid Diagnostics, Inc.
- Study start
- Dec 2026 (estimated)
- Primary completion
- Aug 2033 (estimated)
- Study completion
- Feb 2034 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-site study designed to explore genetic and epigenetic changes in patients with Barrett's esophagus (BE), a condition in which the lining of the esophagus changes and may develop into cancer. The study will include patients with dysplasia (abnormal cell changes) or neoplasia (abnormal tissue growth that may be precancerous or cancerous) who are undergoing endoscopic eradication therapy (EET), a treatment that uses an endoscope (a thin, flexible tube with a camera) to remove or destroy abnormal tissue.
The study will examine genetic changes, such as copy number alterations (changes in the number of copies of specific sections of DNA) and mutations (changes in the DNA sequence), as well as epigenetic changes, such as abnormal DNA methylation (chemical changes that can affect how genes work without changing the DNA sequence). The investigators will assess whether the disappearance or persistence of specific molecular markers associated with the development of abnormal tissue and cancer in Barrett's esophagus can help predict treatment success or failure and the return of precancerous or cancerous tissue after treatment.
Eligible participants undergoing endoscopic eradication therapy will be enrolled in the study. Relevant medical information and biological samples will be collected during endoscopic procedures performed as part of routine clinical care and analyzed for the study. This single-site study is intended to generate preliminary findings to guide future research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Eradication Therapy (EET) | – | Other: TissuePatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing endoscopic eradication therapy (EET) - 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) as part of their routine clinical care.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Younger than age 18 years
- Patients with non-dysplastic BE (NDBE) or are indefinite for dysplasia (IND).
- Patients in whom the initial treatment plan includes potential for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD).
- Patients who have already initiated 1 or more rounds of EET before time of consent.
- Patients with concomitant esophageal pathology such as Eosinophilic Esophagitis (EoE) which in the opinion of the investigator may produce confounding biomarker signals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TissueTissue collection during each endoscopic eradication therapy session. | Other | Endoscopic Eradication Therapy (EET) |
Primary outcome
Genetic changes
Time frame: Baseline, up to 5 years
Genetic changes, including copy number alterations and gene mutations, in biopsy samples from patients with Barrett's esophagus and dysplasia or neoplasia undergoing endoscopic eradication therapy (EET) will be documented.
1 secondary outcome
Epigenetic changes
Time frame: Baseline, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Barrett's Esophagus
RecruitingObservational study
Impact of RFA on Esophageal Distensibility and Mucosal Impedance
Dysplastic Barrett's Esophagus, Radiofrequency Ablation
Active, not recruitingObservational study
Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Barrett Esophagus, Barretts Esophagus With Dysplasia
Active, not recruiting
Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule
Barrett's Esophagus
Active, not recruiting
Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Barrett Esophagus
Enrolling by invitationObservational study
Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma
Barrett Esophagus, Esophageal Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas Shaheen, MD, MPH principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett's Esophagus and Barrett's Esophagus With Dysplasia, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shilpa Karanjit (+1 (919) 843-8519, shilpa_karanjit@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic changes (time frame: Baseline, up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.