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NCT04316975 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
NA
Development phase
75
Enrollment target

NCT04316975: Completed NA study, sponsored by University of North Carolina, Chapel Hill.

NCT04316975 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 75 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04316975, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
NA
Development phase
75 participants
Enrollment target

Study Summary

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).

Primary Outcome

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.

Interventions

  • OTHER Study Driven Procurement of Biopsies

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2020-04-10
Est. Completion 2023-12-20
Phase NA

What the finished NCT04316975 record still lists

NCT04316975 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Study Driven Procurement of Biopsies is the first listed.

NCT04316975 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04316975 about?

NCT04316975 is a clinical study titled "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...

What is the current status of trial NCT04316975?

This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2020-04-10. Estimated completion is 2023-12-20.

What interventions are being tested in trial NCT04316975?

The interventions under investigation include: Study Driven Procurement of Biopsies (OTHER).

Who is sponsoring clinical trial NCT04316975?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04316975's enrollment target sits among peer trials

75 1069th of 2000 higher than 919 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04316975, the US trial registry maintained by the National Library of Medicine. NCT04316975 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.