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Completed

NCT Number: NCT04316975

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

To evaluate association between mutational load (ML) from esophageal biopsy specimens in pre-endoscopic eradication therapy (EET) in Barrett's Esophagus (BE) or Intramucosal adenocarcinoma (IMC) patients and treatment resistance (treatment resistance will be defined as disease recurrence and/or need for additional intervention such as increased acid suppression, need for anti-reflux surgery, or use of alternate ablative modality).

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Key information

Conditions

Barretts Esophagus With Dysplasia Intramucosal Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

Potential subjects will be identified via protocol and Institutional Review Board (IRB) methods prior to obtaining written informed consent. Once written informed consent is obtained, subjects will continue with planned routine care upper endoscopy. During the first study visit an upper endoscopy will be performed. At this visit, research specimens will be obtained for mutational load (ML) analysis and gastroenterologist (GI) pathologist diagnosis for the presence of adenocarcinoma or degrees of dysplasia. ML will be correlated to the pathology diagnosis on this research biopsy. Subjects will then undergo EET per routine standard of care at the treating institution until CEIM achieved. Subjects will be followed (data collection only) during treatment period until CEIM is achieved. After subjects reach CEIM, four additional research biopsies will be collected, from the midpoint of previous BE site.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No prior history of endoscopic treatment therapy for BE
  • Previously untreated "treatment naïve" disease history with confirmed histopathology analysis of at least one of the following:
  • Low- or high-grade dysplastic BE (history of endoscopic mucosal resection (EMR)) is allowable or
  • Intramucosal adenocarcinoma (IMC)
  • BE lesion length of at least: C0, M1
  • At least 18 years of age at time of consent
  • Able and willing to provide written informed consent
  • Able and willing to comply with required study procedures and follow-up schedule

Exclusion criteria

  • History of endoscopic intervention for the treatment of gastroesophageal reflux disease (GERD), BE, or IMC (prior EMR is allowable)
  • Current esophageal stenosis/stricture preventing advancement of a therapeutic scope or significant esophageal anatomic abnormalities (masses, obstructive lesions, etc.)
  • Dysplasia of intestinal metaplasia (IM) confined only to the gastric cardia (BE Prague Criteria: C0M0)
  • Uncontrolled coagulopathy
  • Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist
  • Known portal hypertension, visible esophageal varices, or history of esophageal varices
  • Previous esophagectomy surgery involving the gastroesophageal junction (history of a fundoplication is OK)
  • General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation
  • Subject has any condition that, in the opinion of the investigator or sponsor, would interfere with accurate interpretation of the study endpoints or preclude participation in the trial

Treatment and study plan

Study Driven Procurement of Biopsies

Other

Four research biopsies collected at the midpoint of current BE or IMC at Baseline and after reaching CEIM. Biopsies will be used to calculate ML scores both pre and post EET.

Other names: Research Biopsies

Primary outcomes

  1. Correlation of Mean Mutational Load (ML) and Treatment Resistance

    Time frame: Baseline until Month 24

    Treatment resistance will be assessed as a dichotomous variable and defined as those with one or more of the following features: disease recurrence, need for increased acid suppression, need for anti-reflux surgery, or use of alternate ablative modality. The association between pre-EET ML and treatment resistance will be calculated using the difference between the two mean ML values.

Secondary outcomes

  1. Correlation of Mutational Load and Dysplasia Category

    Time frame: Day 1, at enrollment

    The worst pathologic diagnosis at baseline will be recorded and ML between the three dysplasia groups (low grade dysplasia, high grade dysplasia, and esophageal adenocarcinoma) will be compared.

  2. Correlation of Mutational Load and Number of Ablation Sessions to CEIM

    Time frame: From Baseline until the date of first documentation of CEIM, assessed up to 24 Months

    ML calculation will be compared to number of sessions required to achieve CEIM.

  3. Correlation of Mutational Load and Stricture Formation

    Time frame: From Baseline until the date of first documentation of CEIM, assessed up to 24 Months

    ML calculation will be compared to stricture rates.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Interpace Diagnostics Corporation

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 20, 2020
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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