Novel Mucosal Sampling Technology for Gastric Neoplasia: Wide-area Trans-epithelial Gastric Sampling for the Detection of Premalignant Lesions and Early Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Novel Mucosal Sampling Technology for Gastric Neoplasia: Wide-area Trans-epithelial Gastric Sampling for the Detection of Premalignant Lesions and Early Gastric Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05028296
• Other study ID #: I300005627
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2021
• Source: University of Alabama at Birmingham
• Contact: Douglas Morgan, MD
• Phone: 205-975-9564
• Email: drmorgan[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to compare the diagnostic yields of the WATS approach versus the updated Sydney protocol (five standard biopsies in the three gastric regions). • We hypothesize that the WATS technology will increase the overall diagnostic yield up to 35% of gastric premalignant lesions and early gastric cancer. To explore the performance of the existing and novel biomarkers, including the IHCs p53 and MUC2. - We anticipate concordance of the existing biomarkers as adjuncts to the diagnosis. - To accomplish this aim, we will analyze current biomarkers on all study subjects (Aim 1), as well as explore novel gastric biomarkers.

Description:

We expect that this study will advance the field of gastric cancer early detection, surveillance and prevention. - We hypothesize that a streamlined clinical protocol and SOP will emerge. - We anticipate that this approach will enhance clinical practice as it has in Barrett's esophagus. This comes at a time when endoscopy imaging capabilities are advancing to eventually permit targeted sampling by WATS. - We expect novel biomarkers to be incorporated into WATS clinical practice for gastric neoplasia, based upon discovery (Aim 2). - We will advance the implementation science as we elucidate the barriers to gastric cancer screening in the diverse populations in this study (Scarinci). - We fully expect this study to alter clinical practice and to develop into a variety of ongoing funding pathways. We hypothesize that the WATS will increase the overall histology diagnostic yield by up to 35% and the specific diagnostic yield of gastric intestinal metaplasia (from 20% to 30%), and dysplasia (from 2% to 10%) and early gastric cancer (from 1% to 3%). The examination of novel WATS biomarkers (IHCs) such as gH2AX and the mucins (Aim 2) is exploratory.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with indication for upper endoscopy

Related Conditions & MeSH terms

• Gastric Cancer
• Precancerous Conditions
• Stomach Neoplasms

Intervention

Device:
• WATS Sampling
WATS sampling and analysis in the stomach compartments (antrium, incisira, corpus)

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the diagnostic yields of the WATS approach versus the updated Sydney protocol		36 months
Secondary	To explore the performance of the existing and novel biomarkers, including the IHCs p53 and MUC2		36 months