WATS Sampling for Stomach Cancer

DM
Overseen ByDouglas Morgan, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method called WATS Sampling (Wide Area Transepithelial Sampling) to determine if it can detect early signs of stomach cancer more effectively than the usual biopsy method. Researchers believe WATS could improve the detection of early stomach issues by up to 35%. They will also examine certain markers in the body that could aid in diagnosing stomach problems. The trial seeks participants already scheduled for an upper endoscopy, a procedure to examine the stomach. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance early detection methods for stomach cancer.

What prior data suggests that the WATS Sampling technique is safe for diagnosing stomach cancer?

Research has shown that WATS (Wide Area Transepithelial Sampling) safely checks for stomach problems. Studies using WATS alongside traditional methods found that patients tolerate it well, with no major safety issues reported.

One study found that WATS identified certain conditions more effectively without causing significant side effects, indicating its general safety for patients undergoing the test. Although not all safety data is available, using WATS with other diagnostic tools has not revealed any major safety concerns.12345

Why are researchers excited about this trial?

Researchers are excited about WATS Sampling for stomach cancer because it offers a new way to detect cancerous cells that might be missed by traditional biopsy methods. Unlike standard endoscopic procedures that rely on random tissue samples, WATS Sampling uses a brush to collect a broader range of tissue, potentially uncovering abnormalities more effectively. This technique aims to improve early detection rates, which is crucial for better treatment outcomes and survival rates.

What evidence suggests that the WATS Sampling is effective for diagnosing stomach cancer?

Research has shown that WATS Sampling, or Wide Area Transepithelial Sampling, holds promise for detecting early cancer signs. Previous studies demonstrated that adding WATS3D increased the detection of precancerous changes in the esophagus, such as High-Grade Dysplasia and Esophageal Adenocarcinoma, by over 400% compared to traditional methods. It also improved the detection of Low-Grade Dysplasia by nearly 89%. While most research has focused on the esophagus, these findings suggest WATS Sampling might also effectively spot early changes in the stomach. This trial will evaluate WATS Sampling in patients scheduled for standard of care upper endoscopy, using its larger sampling area and advanced imaging to potentially find early cancerous changes that standard biopsies might miss.36789

Who Is on the Research Team?

DM

Douglas Morgan, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Patients Scheduled for Standard of Care Upper EndoscopyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Citations

Wide Area Transepithelial Sampling with Computer ...The addition of WATS3D to the Seattle protocol results in approximately 3 fewer cancers and 3 fewer cancer deaths per 1000 people screened for BE. Furthermore, ...
Utility of wide-area transepithelial sampling with 3 ...The absolute yield for IM and dysplasia detection was 16% and 4.4%, respectively, and dysplasia detection was significantly greater in patients with visible BE ...
WATS3D Shown to be over 4X More Effective in Detecting ...The study found that WATS3D increased the detection of High-Grade Dysplasia and Esophageal Adenocarcinoma (HGD/EAC) by more than 400% compared to the standard ...
WATS3D - A SAGES Technology and Value AssessmentAddition of WATS3D to FB increased detection of LGD by 88.5% (23/26; 95% CI 48%–160%). The NNT to detect one additional case of dysplasia was ...
Adjunctive Use of Wide-Area Transepithelial Sampling-3D ...Overall, WATS-3D diagnostic yield for IM was significantly higher than FB in the entire study cohort (25.6% vs 16.3%, P < 0.0001) and in each of the 4 ...
WATS Sampling for Stomach Cancer · Info for ParticipantsWe hypothesize that the WATS technology will increase the overall diagnostic yield up to 35% of gastric premalignant lesions and early gastric cancer.To explore ...
Wide-area transepithelial sampling in adjunct to forceps ...Our study shows that WATS, as an adjunct to FB, improves both the absolute detection rate and relative detection rate of both BE and ED as compared to FB alone.
8.cdxdiagnostics.comcdxdiagnostics.com/wats3d-va
WATS3D for EGDWATS3D is effective at increasing the diagnostic yield of both intestinal metaplasia and associated dysplasia in patients with either short or long segment ...
Wide Area Transepithelial Sampling with Computer- ...Results. Between 320 and 337 people would need to be screened with WATS3D in addition to FB to avert one additional cancer, and 328–367 people ...
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