WATS Sampling for Stomach Cancer

Overseen By Douglas Morgan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 36 months

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Douglas Morgan, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Inclusion Criteria

I need an upper endoscopy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo wide-area trans-epithelial gastric sampling using WATS technology and standard biopsies for diagnostic comparison

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including analysis of biomarkers

4 weeks

Treatment Details

Interventions

• WATS Sampling

Trial Overview 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.

Participant Groups

Group I: Patients Scheduled for Standard of Care Upper Endoscopy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+