Phase II Randomized Trial of Bethesda Protocol Compared to Cambridge Method for Detection of Early Stage Gastric Cancer in CDH1 Mutation Carriers

PHASE2CompletedINTERVENTIONAL
Enrollment

195

Participants

Timeline

Start Date

June 22, 2023

Primary Completion Date

September 12, 2024

Study Completion Date

January 10, 2025

Conditions
Gastric CancerGastric NeoplasmsGastric Adenocarcinoma
Interventions
DEVICE

Cellvizio (Registered trademark) Real-Time In Vivo Cellular Imaging Platform with Confocal Miniprobes

Participants of both study arms will undergo confocal endomicroscopy of the gastric mucosa until sufficient data for statistically accurate and reliable application of machine learning (i.e., computer models), currently believed to total the first 50 enrolled participants.

DEVICE

Olympus Graphics Interchange Format (GIF) 190 endoscope

Participants will undergo white light endoscopy. The mucosa of the stomach may be thoroughly washed before examination, as medically indicated, and inspection will include repeated inflation and deflation to check distensibility and any abnormal appearing areas will additionally be biopsied. Nontargeted biopsies will be obtained as indicated per the assigned Arm.

PROCEDURE

Gastric mucosal biopsy

As clinically indicated.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH