Novel Approach to Surveillance of Gastric Lesions

January 30, 2020 updated by: Monika Laszkowska, New York Presbyterian Hospital

A Novel Approach to the Surveillance of Pre-Malignant Gastric Lesions

This will be a pilot study investigating the feasibility of using pressurized irrigation of the stomach mucosa to obtain gastric aspirate cell samples for analysis and identification of premalignant lesions of the stomach.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Gastric cancer is an important public health concern, accounting for 26,240 new cases in the United States (US) annually. Outcomes are poor, with 5-year survival of 31%, but improve when lesions are detected at early stages amenable to curative therapy. Research has shown that lesions such as atrophic gastritis and gastric intestinal metaplasia are precursors to more advanced lesions such as dysplasia and adenocarcinoma, thus providing a potential target for early intervention. Gastric cancer screening programs have decreased mortality in high-prevalence countries like Japan. However, providers in low-prevalence settings are less experienced at detecting precursor lesions endoscopically on visual inspection. This pilot study will investigate a novel approach to screening for precursor lesions and early detection of gastric cancer by utilizing pressurized irrigation of the gastric mucosa. The study will target patients with a known history of gastric precursor lesions (atrophic gastritis, intestinal metaplasia, history of dysplasia) who are presenting for routine surveillance endoscopy. Following routine endoscopic evaluation, the investigators will utilize the ERBEJET 2 device (ERBE USA Inc), which is commercially available for the treatment of mucosal lesions, to sample cells from the mucosal surface of the stomach. The aspirate will be collected for cytologic/pathologic assessment. The goal is that this technique will simplify testing for precursor lesions of gastric cancer, making screening more effective in regions of lower prevalence where providers are less experienced with visual identification of such lesions.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Early Phase 1

Contacts and Locations

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

Study Contact

Study Contact Backup

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals with a known history of gastric precursor lesions (atrophic gastritis, intestinal metaplasia, history of dysplasia) who are presenting for routine surveillance endoscopy

Exclusion Criteria:

  • Personal history of gastric cancer
  • Personal history of irritable bowel disease

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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mucosal Irrigation
Following routine endoscopic evaluation, investigators will utilize the ERBEJET 2 device (ERBE USA Inc), which is commercially available for the treatment of mucosal lesions, to sample cells from the mucosal surface of the stomach. The aspirate will be collected for cytologic/pathologic assessment.
Diagnostic test: Mucosal Irrigation
Following routine endoscopic evaluation, investigators will utilize the ERBEJET 2 device (ERBE USA Inc), which is commercially available for the treatment of mucosal lesions, to sample cells from the mucosal surface of the stomach. The aspirate will be collected for cytologic/pathologic assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of pathologic diagnosis from gastric aspirate compared with diagnosis from standard endoscopic inspection and biopsies.
Time Frame: Intra-procedural
Investigators will compare how the diagnosis determined from pathologic/cytologic analysis gastric aspirate samples will compare with diagnosis obtained from standard endoscopic inspection and biopsies. The diagnoses of interest will be normal mucosa, atrophic gastritis, intestinal metaplasia, dysplasia, or malignancy. This will be reported as the percentage of concordant diagnoses.
Intra-procedural

Collaborators and Investigators

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

Sponsor

New York Presbyterian Hospital

Investigators

  • Principal Investigator: Charles Lightdale, MD, New York Presbyterian - Columbia University Medical Center

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 (Anticipated)

February 1, 2020

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

January 28, 2020

First Submitted That Met QC Criteria

January 30, 2020

First Posted (Actual)

January 31, 2020

Study Record Updates

Last Update Posted (Actual)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 30, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-AAAS8330

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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