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Procedure

WATS Sampling for Stomach Cancer

N/A
Waitlist Available
Led By Douglas Morgan, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with indication for upper endoscop
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two different methods for diagnosing stomach cancer. The first method, WATS, uses a new technology and the second method, the Sydney protocol, uses five standard biopsies. The trial hypothesizes that the WATS technology will be more effective in diagnosing gastric premalignant lesions and early gastric cancer.

Who is the study for?
This trial is for patients who need an upper endoscopy, which is a procedure where a doctor looks inside the stomach. It's designed to test if a new way of sampling cells from the stomach lining can better detect early signs of cancer or precancerous conditions compared to current methods.
What is being tested?
The study tests WATS (Wide-area Trans-epithelial Sampling) technology against the standard Sydney protocol involving five biopsies in different stomach areas. The goal is to see if WATS improves detection rates by up to 35% for early gastric cancer and pre-cancer lesions.
What are the potential side effects?
Since this trial involves diagnostic procedures rather than medication, side effects are likely related to typical risks of endoscopy such as discomfort, bleeding, or infection at the biopsy site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To compare the diagnostic yields of the WATS approach versus the updated Sydney protocol
Secondary study objectives
To explore the performance of the existing and novel biomarkers, including the IHCs p53 and MUC2

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients Scheduled for Standard of Care Upper EndoscopyExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,656 Previous Clinical Trials
2,444,075 Total Patients Enrolled
Douglas Morgan, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

WATS Sampling (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05028296 — N/A
Stomach Cancer Research Study Groups: Patients Scheduled for Standard of Care Upper Endoscopy
Stomach Cancer Clinical Trial 2023: WATS Sampling Highlights & Side Effects. Trial Name: NCT05028296 — N/A
WATS Sampling (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05028296 — N/A
~77 spots leftby Dec 2025
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