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Not yet recruitingNCT07887568Updated Oct 21, 2026

Lucid BE Biomarkers Study

An observational study in Barrett's Esophagus, Barrett's Esophagus With Dysplasia and Esophageal Adenocarcinoma (EAC), sponsored by UNC Lineberger Comprehensive Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by UNC Lineberger Comprehensive Cancer Center · Observational

Updated Oct 21, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Barrett's Esophagus
  • Barrett's Esophagus With Dysplasia
  • Esophageal Adenocarcinoma (EAC)

Keywords

  • Barrett's Esophagus
03

In context

Barrett Esophagus

316 studies on the registry are indexed under Barrett Esophagus; 62 are open to participants now.

This study's planned enrollment of 40 is below the median of 137 across 117 observational studies indexed under Barrett Esophagus.

Browse Barrett Esophagus studies →

Lead sponsor

UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 424 studies on the registry; 96 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
  2. Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
  3. Age ≥ 18 years at the time of consent.
  4. 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).
  5. Have not yet initiated first session of endoscopic eradication therapy (EET1) at the time of consent.

Exclusion criteria

Exclusion Criteria:

  1. Younger than age 18 years
  2. Patients with non-dysplastic BE (NDBE) or are indefinite for dysplasia (IND).
  3. Patients in whom the initial treatment plan includes potential for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD).
  4. Patients who have already initiated 1 or more rounds of EET before time of consent.
  5. Patients with concomitant esophageal pathology such as Eosinophilic Esophagitis (EoE) which in the opinion of the investigator may produce confounding biomarker signals.
  6. Patients in which even a limited number of biopsies during Esophagogastroduodenoscopy (EGD) would be contraindicated.
  7. 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).
  8. Known bleeding disorder.
  9. 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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).

    Other: Tissue

Interventions

  • OtherTissue

    Tissue collection during each endoscopic eradication therapy session.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Baseline, up to 5 years

07

Study locations

1 site
  • UNC Chapel Hill
    Chapel Hill, North Carolina 27599, United States
08

References and documents

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07887568
Collaborators
Lucid Diagnostics, Inc.
Responsible party
Sponsor
First posted
Oct 21, 2026
Start date
Dec 2026 (estimated)
Primary completion
Aug 2033 (estimated)
Completion
Feb 2034 (estimated)
Last update
Oct 21, 2026

Study contacts

Shilpa Karanjit
Contact
shilpa_karanjit@med.unc.edu
+1 (919) 843-8519
Nicholas Shaheen, MD, MPH
principal investigator · UNC Chapel Hill

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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