Novel Screening Modality for Early Gastric Cancer

September 8, 2023 updated by: Douglas Morgan MD, University of Alabama at Birmingham

Initial Analysis of Wide-area Transepithelial Sampling for the Detection of Gastric Neoplasia

Potential patients will be recruited at participating sites based on routine care with clinical indications for upper endoscopy. Following informed consent, patients will undergo their scheduled endoscopy with standard forceps biopsies along with the transepithelial brush samples. All samples, biopsy and brush samples, will be sent for pathology analysis, per standard clinical practice.

Study Overview

Status

Completed

Conditions

Detailed Description

Potential patients will be recruited at participating sites based on routine care with clinical indications for upper endoscopy. Following informed consent, patients will undergo their scheduled endoscopy with standard forceps biopsies along with the transepithelial brush samples. All samples, biopsy and brush samples, will be sent for histologic analysis, with planned study of the diagnostic yields of each method.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Honduras
    • Copan
      • Santa Rosa De Copán, Copan, Honduras, 41101
        • Hospital de Occidente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with indications for upper endoscopy (e.g. dyspepsia)

Description

Inclusion Criteria:

  • Subject is informed of the investigational nature of this study and given verbal and written informed consent in accordance with local, U.S., and international guidelines.
  • Both males and females at least 18 years.
  • Patients with clinical indications for upper endoscopy

Exclusion Criteria:

  • Patients should not have an advanced medical or psychiatric conditions which that may limit their ability to participate in the study, as judged by the physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield of the WATS approach versus standard gastric biopsy mapping
Time Frame: 1-3 Years
To compare the diagnostic yield of the WATS approach versus standard gastric biopsy mapping (per the updated Sydney system).
1-3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Douglas Morgan, MD, MPH, University of Alabama at Birmingham
  • Principal Investigator: Ricardo Dominguez, MD, Hospital de Occidente Honduras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

March 15, 2023

Study Completion (Actual)

March 15, 2023

Study Registration Dates

First Submitted

October 1, 2019

First Submitted That Met QC Criteria

October 2, 2019

First Posted (Actual)

October 3, 2019

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00001470

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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