Lucid BE Biomarkers Study

NCT07887568 | Not Yet Recruiting

• 1 other identifier: LCCC2620
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Barrett's Esophagus

Outcome Measures

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.

  Baseline, up to 5 years

Secondary Outcomes (1)

• Epigenetic changes

  Baseline, up to 5 years

Study Arms (1)

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

Tissue OTHER

Tissue collection during each endoscopic eradication therapy session.

Endoscopic Eradication Therapy (EET)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Lucid Diagnostics, Inc.: collaborator

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Esophageal biopsies (small tissue samples) Esophageal brushes (brushings of esophageal tissue)

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus

Interventions

Histocompatibility Testing

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Nicholas Shaheen, MD, MPH

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shilpa Karanjit

CONTACT

+1 (919) 843-8519; shilpa_karanjit@med.unc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): August 1, 2033
• Study Completion (Estimated): February 1, 2034
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)