NCT00431756

Brief Summary

The purpose of this study is to determine if there are any early changes in DNA markers of blood and esophageal tissue in people with gastric reflux, Barrett's esophagus or esophageal cancer that can warn of a progression to esophageal cancer.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started May 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

May 1, 2002

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2007

Completed
16.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

21 years

First QC Date

February 2, 2007

Last Update Submit

December 11, 2025

Conditions

Barrett EsophagusEsophageal NeoplasmGastroesophageal Reflux

Keywords

Barrett's esophagusgastroesophageal reflux disease (GERD)esophageal cancerDNA methylation

Outcome Measures

Primary Outcomes (1)

  • early predictors of esophageal cancer

    To see if changes in certain areas of DNA can predict risk for esophageal cancer

    3

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People scheduled for endoscopy at Johns Hopkins who have esophageal cancer, Barrett's esophagus or gastro-esophageal reflux disease

You may qualify if:

  • People who are undergoing upper endoscopy as part of their medical care with a history of esophageal cancer, Barrett's esophagus, or upper gastrointestinal symptoms.

You may not qualify if:

  • People who are are currently having chemotherapy, or who have completed chemotherapy within the last 4 weeks.
  • People who have ever had radiation treatments to their chest.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

approx. 24 ml blood, 1-8 esophageal mucosal pinch specimens and or esophageal brushings

MeSH Terms

Conditions

Barrett EsophagusEsophageal NeoplasmsGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEsophageal Motility DisordersDeglutition Disorders

Study Officials

  • Marcia Canto, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2007

First Posted

February 6, 2007

Study Start

May 1, 2002

Primary Completion

May 1, 2023

Study Completion (Estimated)

June 1, 2026

Last Updated

December 16, 2025

Record last verified: 2025-12

Locations

US(1)