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NCT07887568
Lucid BE Biomarkers Study
Conditions: Barrett's Esophagus, Barrett's Esophagus With Dysplasia, Esophageal Adenocarcinoma (EAC)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 40
Sponsor: UNC Lineberger Comprehensive Cancer Center
Location: UNC Chapel Hill Chapel Hill North Carolina
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.
Eligibility Criteria
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:
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.
Source: ClinicalTrials.gov (NCT07887568). StuddyBuddy aggregates publicly available trial information.