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Study-Driven Biopsy Procurement for Barrett's Esophagus

N/A

Waitlist Available

Led By Nicholas J Shaheen, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline until month 24

Awards & highlights

Study Summary

This trial will study whether there is a correlation between the number of mutations in a patient's esophageal tissue and that patient's resistance to treatment for Barrett's Esophagus or Intramucosal Adenocarcinoma.

Eligible Conditions

Barrett's Esophagus with Dysplasia
Adenocarcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline until month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline until month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline until month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

DNA Mutational Analysis

Secondary outcome measures

Correlation of Mutational Load and Dysplasia Category

Correlation of Mutational Load and Number of Ablation Sessions to CEIM

Anorectal stricture

Trial Design

1Treatment groups

Experimental Treatment

Group I: Biopsy: Barrett's Esophagus, Intramucosal adenocarcinomaExperimental Treatment1 Intervention

Subjects will undergo standard of care (SOC) standard esophagogastroduodenoscopy (EGD) for the treatment of their condition (BE or IMC). Four (4) research biopsies will be taken from the midpoint of current disease. In cases where EMR (Endoscopic Mucosal Resection) is performed clinically, no research biopsies will be taken. Following CEIM, four (4) additional research biopsies will be collected, from the midpoint of previous BE site. Laboratory Biomarker Analysis: Correlative studies Esophagogastroduodenoscopy: Standard of care, research biopsies will be collected if clinical biopsies are taken

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Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,506 Previous Clinical Trials

4,190,486 Total Patients Enrolled

Interpace Diagnostics CorporationUNKNOWN

Nicholas J Shaheen, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

2 Previous Clinical Trials

5,648 Total Patients Enrolled

Media Library

Biopsy: Barrett's Esophagus, Intramucosal adenocarcinoma Clinical Trial Eligibility Overview. Trial Name: NCT04316975 — N/A

Barrett's Esophagus Research Study Groups: Biopsy: Barrett's Esophagus, Intramucosal adenocarcinoma

Barrett's Esophagus Clinical Trial 2023: Biopsy: Barrett's Esophagus, Intramucosal adenocarcinoma Highlights & Side Effects. Trial Name: NCT04316975 — N/A

Biopsy: Barrett's Esophagus, Intramucosal adenocarcinoma 2023 Treatment Timeline for Medical Study. Trial Name: NCT04316975 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial currently accepting new participants?

"According to the information on clinicaltrials.gov, this particular trial is no longer seeking out new patients; its last update occurred on May 5th 2022. Fortunately, 36 other medical studies are recruiting volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Utility Of Mutational Load As A Predictor For Endoscopic Treatment Response In Barrett's Esophagus

2020. "Utility Of Mutational Load As A Predictor For Endoscopic Treatment Response In Barrett's Esophagus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04316975.