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Patients with Low-Grade Dysplasia or Long Segment Barrett's Esophagus [ValidationCohort] for Esophageal Cancer (EMERALD Trial)

N/A
Recruiting
Led By Ajay Goel, PhD
Research Sponsored by City of Hope Medical Center
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 through study completion, an average of 1 year
Awards & highlights

EMERALD Trial 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.

Eligible Conditions
  • Esophageal Cancer
  • Barrett's Esophagus
  • Esophageal Dysplasia
  • Barrett's Adenocarcinoma
  • GERD
  • Acid Reflux
  • Barrett's esophagus
  • Esophageal Adenocarcinoma

EMERALD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sensitivity
Secondary outcome measures
Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy)
Specificity

EMERALD Trial Design

10Treatment groups
Experimental Treatment
Group I: Patients with Low-Grade Dysplasia or Long Segment Barrett's Esophagus [ValidationCohort]Experimental Treatment1 Intervention
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
Group II: Patients with Low-Grade Dysplasia or Long Segment Barrett's Esophagus [Test Cohort]Experimental Treatment1 Intervention
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
Group III: Patients with Esophageal Adenocarcinoma or High-Grade Dysplasia Barrett's Esophagus [Validation]Experimental Treatment1 Intervention
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)
Group IV: Patients with Esophageal Adenocarcinoma or High-Grade Dysplasia Barrett's Esophagus [Training]Experimental Treatment1 Intervention
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)
Group V: Patients with Esophageal Adenocarcinoma or High-Grade Dysplasia Barrett's Esophagus [Test Cohort]Experimental Treatment1 Intervention
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)
Group VI: Patients with Esophageal Adenocarcinoma [Matching Normal Tissue]Experimental Treatment1 Intervention
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)
Group VII: Patients with Esophageal Adenocarcinoma [Malignant Tissue]Experimental Treatment1 Intervention
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)
Group VIII: Individuals Without Esophageal Adenocarcinoma or Barrett's Esophagus [Validation Cohort]Experimental Treatment1 Intervention
Individuals who underwent endoscopy and were found not to have any Barrett's Esophagus or adenocarcinoma.
Group IX: Individuals Without Esophageal Adenocarcinoma or Barrett's Esophagus [Training Cohort]Experimental Treatment1 Intervention
Individuals who underwent endoscopy and were found not to have any Barrett's Esophagus or adenocarcinoma.
Group X: Individuals Without Esophageal Adenocarcinoma or Barrett's Esophagus [Test Cohort]Experimental Treatment1 Intervention
Individuals who underwent endoscopy and were found not to have any Barrett's Esophagus or adenocarcinoma.

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
568 Previous Clinical Trials
1,923,660 Total Patients Enrolled
Ajay Goel, PhDPrincipal InvestigatorCity of Hope Medical Center
9 Previous Clinical Trials
6,577 Total Patients Enrolled

Frequently Asked Questions

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