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Novel Approach to Surveillance of Gastric Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251403
Recruitment Status : Not yet recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Monika Laszkowska, New York Presbyterian Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intestinal Metaplasia of Gastric Mucosa Gastric Dysplasia Gastric Cancer Atrophic Gastritis Diagnostic Test: Mucosal Irrigation Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a pilot feasibility study. High-risk individuals with known history of gastric precursor lesions (atrophic gastritis, intestinal metaplasia, dysplasia) who are presenting for routine surveillance endoscopy will undergo mucosal irrigation and collection of gastric aspirate for analysis, in addition to standard of care (visual inspection on endoscopy).
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Novel Approach to the Surveillance of Pre-Malignant Gastric Lesions
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251403


Contacts
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Contact: Monika Laszkowska, MD 9179747218 ml3228@cumc.columbia.edu
Contact: Charles Lightdale, MD (212) 305-3423 cjl18@cumc.columbia.edu

Sponsors and Collaborators
New York Presbyterian Hospital
Investigators
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Principal Investigator: Charles Lightdale, MD New York Presbyterian - Columbia University Medical Center
Publications:
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Responsible Party: Monika Laszkowska, Principal Investigator, New York Presbyterian Hospital
ClinicalTrials.gov Identifier: NCT04251403    
Other Study ID Numbers: IRB-AAAS8330
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Gastritis
Gastritis, Atrophic
Metaplasia
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Gastroenteritis
Pathologic Processes