NCT07335445

Brief Summary

Previous studies have shown that screening for Barrett's esophagus (BE), the main risk factor for esophageal adenocarcinoma, is under-utilized in the primary care setting. In fact less than 35% of eligible patients are screened despite endorsement for screening by the major GI societies in patients with risk factors. The purpose of this study is to examine current screening practices and determine if implementation of screening reminders can optimize screening practices for Barrett's Esophagus within a large, academic based healthcare system in NJ.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
38mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress1%
May 2026Jun 2029

First Submitted

Initial submission to the registry

January 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

May 5, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

January 5, 2026

Last Update Submit

May 3, 2026

Conditions

Barrett's Esophagus

Keywords

screeningbarrett's esophagusbarrett's

Outcome Measures

Primary Outcomes (1)

  • BE screening rate

    Percentage increase in BE screening compared to each arm's historical control BE screening rate from the year prior.

    1 year

Study Arms (2)

Standard of Care

NO INTERVENTION

Intervention

ACTIVE COMPARATOR
Other: Screening Reminder

Interventions

Screening ReminderOTHER

A reminder to screen this patient for Barrett's esophagus (BE) will be sent to the provider before the patient's scheduled appointment. The reminder will provide details about which criteria this patient meets in order to indicate that BE screening should be initiated.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Have a scheduled appointment with a participating provider

You may not qualify if:

  • Less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (4)

  • Muthusamy VR, Wani S, Gyawali CP, Komanduri S; CGIT Barrett's Esophagus Consensus Conference Participants. AGA Clinical Practice Update on New Technology and Innovation for Surveillance and Screening in Barrett's Esophagus: Expert Review. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2696-2706.e1. doi: 10.1016/j.cgh.2022.06.003. Epub 2022 Jul 3.

    PMID: 35788412BACKGROUND

  • Saha B, Vantanasiri K, Mohan BP, Goyal R, Garg N, Gerberi D, Kisiel JB, Singh S, Iyer PG. Prevalence of Barrett's Esophagus and Esophageal Adenocarcinoma With and Without Gastroesophageal Reflux: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2024 Jul;22(7):1381-1394.e7. doi: 10.1016/j.cgh.2023.10.006. Epub 2023 Oct 24.

    PMID: 37879525BACKGROUND

  • Sawas T, Zamani SA, Killcoyne S, Dullea A, Wang KK, Iyer PG, Fitzgerald RC, Katzka DA. Limitations of Heartburn and Other Societies' Criteria in Barrett's Screening for Detecting De Novo Esophageal Adenocarcinoma. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1709-1718. doi: 10.1016/j.cgh.2021.10.039. Epub 2021 Oct 29.

    PMID: 34757196BACKGROUND

  • Nguyen TH, Thrift AP, Rugge M, El-Serag HB. Prevalence of Barrett's esophagus and performance of societal screening guidelines in an unreferred primary care population of U.S. veterans. Gastrointest Endosc. 2021 Feb;93(2):409-419.e1. doi: 10.1016/j.gie.2020.06.032. Epub 2020 Jun 19.

    PMID: 32565183BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Arvind Trindade, MD

    Professor of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Molly Stewart

CONTACT

732-235-3247molly.stewart1@rutgers.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 13, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

May 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported, following deidentification. Data will only be shared upon request, for an approved proposal, after review and approval by Rutgers University.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Beginning 3 months and ending 5 years following publication.
Access Criteria
Researchers who provide a methodologically sound proposal, following approval by Rutgers University.

Locations

US(1)