NCT03853772

Brief Summary

A multi-center, multi-year registry of patients with gastroesophageal reflux disease (GERD) undergoing diagnostic evaluation and/or treatment of GERD and associated diseases and complications.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
enrolling by invitation

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 Progress87%
Apr 2019Jun 2027

First Submitted

Initial submission to the registry

February 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 27, 2019

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

7.6 years

First QC Date

February 22, 2019

Last Update Submit

December 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Demographic and clinical data obtained via chart review and questionnaires

    Establish a registry with collected data related to patients undergoing diagnostic evaluation and treatment of GERD and its associated diseases in multiple academic and community settings.

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients referred by physicians having diagnostic evaluation or treatment for GERD.

You may qualify if:

  • Referred GERD patients willing to participate in long term follow-up (5 years)

You may not qualify if:

  • Potential participants will be excluded if unwilling or unable to complete surveillance questionnaires through this registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

UCI-Irvine

Orange, California, 92868, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

UNRMed-University of Nevada, Reno

Reno, Nevada, 89557, United States

Location

Weill Cornell

New York, New York, 10065, United States

Location

Geisinger

Danville, Pennsylvania, 17822, United States

Location

The Matagorda Regional Medical Group

Bay City, Texas, 77414, United States

Location

UT Health

Houston, Texas, 77030, United States

Location

Fox Valley Surgical Associates

Appleton, Wisconsin, 54911, United States

Location

MeSH Terms

Conditions

Gastroesophageal RefluxBarrett EsophagusLaryngopharyngeal RefluxEsophagitis

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPrecancerous ConditionsNeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesGastroenteritis

Study Officials

  • Marcia Canto, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2019

First Posted

February 26, 2019

Study Start

April 27, 2019

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Research projects will be submitted to host (currently JHU) and accepted project will be granted access to read only de-identified database.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
minimum 6 years
Access Criteria
Project submission to PI and or Heartburn Registry management team then if project accepted, security clearance and enrollment in REDCap and tutorial completions.

Locations