NCT06381583

Brief Summary

This study aims to develop a highly sensitive, specific, and cost-effective blood assay for the early detection of esophageal adenocarcinoma and its precursor lesions, using advanced machine learning and state-of-the-art biological analyses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
658

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 19, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2024

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

April 19, 2024

Last Update Submit

May 8, 2024

Conditions

Esophagus CancerEsophageal Cancer StageEsophageal CancerEsophageal NeoplasmsEsophagus AdenocarcinomaEsophagus, BarrettBarrett EsophagusBarrett AdenocarcinomaBarrett EpitheliumBarretts Esophagus With DysplasiaBarrett's Esophagus Without DysplasiaBarretts Esophagus With High Grade DysplasiaBarretts Esophagus With Low Grade DysplasiaBarrett Esophagus, Long-SegmentBarrett's Esophagus With Dysplasia, UnspecifiedBarrett's Esophagus With EsophagitisGastroesophageal RefluxReflux DiseaseEsophageal AdenocarcinomaEsophageal DysplasiaEsophageal Neoplasms Malignant

Keywords

Early detectionMicro RNAmiRNALiquid biopsyDysplasiaArtificial IntelligenceCancer detectionLong segment Barrett EsophagusScreeningSurveillance

Outcome Measures

Primary Outcomes (1)

  • Sensitivity

    True positive rate: the probability of a positive test result, conditioned on the individual truly being positive

    Through study completion, an average of 1 year

Secondary Outcomes (2)

  • Specificity

    Through study completion, an average of 1 year

  • Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy)

    Through study completion, an average of 1 year

Study Arms (10)

Patients with Esophageal Adenocarcinoma [Malignant Tissue]

Individuals who underwent endoscopy and were found to only have one of the following: * Esophageal adenocarcinoma of any stage * Esophageal adenocarcinoma confined to the mucosa (stage Tis)

Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)

Patients with Esophageal Adenocarcinoma [Matching Normal Tissue]

Individuals who underwent endoscopy and were found to only have one of the following: * Esophageal adenocarcinoma of any stage * Esophageal adenocarcinoma confined to the mucosa (stage Tis)

Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)

Patients with Esophageal Adenocarcinoma or High-Grade Dysplasia Barrett's Esophagus [Test Cohort]

Individuals who underwent endoscopy and were found to only have one of the following: * Barrett's Esophagus, with high-grade dysplasia, independently of Barrett's segment length * Esophageal adenocarcinoma of any stage * Esophageal adenocarcinoma confined to the mucosa (stage Tis)

Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)

Patients with Low-Grade Dysplasia or Long Segment Barrett's Esophagus [Test Cohort]

Individuals who underwent endoscopy and were found to only have Barrett's Esophagus, with one of the following: * Craniocaudal maximal extension of 3 cm or more * Low-grade dysplasia at most, independently of Barrett's segment length

Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)

Individuals Without Esophageal Adenocarcinoma or Barrett's Esophagus [Test Cohort]

Individuals who underwent endoscopy and were found not to have any Barrett's Esophagus or adenocarcinoma.

Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)

Patients with Esophageal Adenocarcinoma or High-Grade Dysplasia Barrett's Esophagus [Training]

Individuals who underwent endoscopy and were found to only have one of the following: * Barrett's Esophagus, with high-grade dysplasia, independently of Barrett's segment length * Esophageal adenocarcinoma of any stage * Esophageal adenocarcinoma confined to the mucosa (stage Tis)

Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)

Individuals Without Esophageal Adenocarcinoma or Barrett's Esophagus [Training Cohort]

Individuals who underwent endoscopy and were found not to have any Barrett's Esophagus or adenocarcinoma.

Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)

Patients with Esophageal Adenocarcinoma or High-Grade Dysplasia Barrett's Esophagus [Validation]

Individuals who underwent endoscopy and were found to only have one of the following: * Barrett's Esophagus, with high-grade dysplasia, independently of Barrett's segment length * Esophageal adenocarcinoma of any stage * Esophageal adenocarcinoma confined to the mucosa (stage Tis)

Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)

Patients with Low-Grade Dysplasia or Long Segment Barrett's Esophagus [ValidationCohort]

Individuals who underwent endoscopy and were found to only have Barrett's Esophagus, with one of the following: * Craniocaudal maximal extension of 3 cm or more * Low-grade dysplasia at most, independently of Barrett's segment length

Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)

Individuals Without Esophageal Adenocarcinoma or Barrett's Esophagus [Validation Cohort]

Individuals who underwent endoscopy and were found not to have any Barrett's Esophagus or adenocarcinoma.

Diagnostic Test: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)

Interventions

EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia)DIAGNOSTIC_TEST

A panel of circulating microRNA, whose expression level is tested in cell-free derived samples.

Individuals Without Esophageal Adenocarcinoma or Barrett's Esophagus [Test Cohort]Individuals Without Esophageal Adenocarcinoma or Barrett's Esophagus [Training Cohort]Individuals Without Esophageal Adenocarcinoma or Barrett's Esophagus [Validation Cohort]Patients with Esophageal Adenocarcinoma [Malignant Tissue]Patients with Esophageal Adenocarcinoma [Matching Normal Tissue]Patients with Esophageal Adenocarcinoma or High-Grade Dysplasia Barrett's Esophagus [Test Cohort]Patients with Esophageal Adenocarcinoma or High-Grade Dysplasia Barrett's Esophagus [Training]Patients with Esophageal Adenocarcinoma or High-Grade Dysplasia Barrett's Esophagus [Validation]Patients with Low-Grade Dysplasia or Long Segment Barrett's Esophagus [Test Cohort]Patients with Low-Grade Dysplasia or Long Segment Barrett's Esophagus [ValidationCohort]

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Four independent cohorts of individuals who belong to one of the following five Negative endoscopic findings Barrett's esophagus, at least 3 cm long without low-grade dysplasia (at most) Barrett's esophagus, of any length, with low-grade dysplasia (at most) Barrett's esophagus, of any length, with high-grade dysplasia (at most) Esophageal adenocarcinoma (of any stage, including in situ \[Tis\]) Colorectal cancer

You may qualify if:

  • All individuals included in the study need to have had an endoscopic evaluation at the time of blood sampling.
  • Received standard diagnostic and staging (as necessary) procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.
  • Received standard pathological and endoscopic diagnosis and assessment for cohort assignment.

You may not qualify if:

  • Lack of written informed consent.
  • Short segment Barrett's esophagus with no evidence of dysplasia
  • Ultra-short segment Barrett's esophagus with no evidence of dysplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91016, United States

Location

Related Publications (1)

  • Miyoshi J, Mannucci A, Scarpa M, Gao F, Toden S, Whitsett T, Inge LJ, Bremner RM, Takayama T, Cheng Y, Bottiglieri T, Nagtegaal ID, Shrubsole MJ, Zaidi AH, Wang X, Coleman HG, Anderson LA, Meltzer SJ, Goel A; FINBAR-EMERALD collaborative group. Liquid biopsy to identify Barrett's oesophagus, dysplasia and oesophageal adenocarcinoma: the EMERALD multicentre study. Gut. 2025 Jan 17;74(2):169-181. doi: 10.1136/gutjnl-2024-333364.

    PMID: 39562048DERIVED

MeSH Terms

Conditions

Esophageal NeoplasmsAdenocarcinoma Of EsophagusBarrett EsophagusGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesPrecancerous ConditionsEsophageal Motility DisordersDeglutition Disorders

Study Officials

  • Ajay Goel, PhD

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2024

First Posted

April 24, 2024

Study Start

April 15, 2023

Primary Completion

April 24, 2024

Study Completion

April 24, 2024

Last Updated

May 10, 2024

Record last verified: 2024-05

Locations

US(1)