NCT05566899

Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy

Primary Objective: The Primary Objective of the Study is to Evaluate the Acceptability and Feasibility of EGD-SC

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Screening esophagogastroduodenoscopy (EGD )provides three distinct opportunities to decrease gastric cancer (GC) morbidity and mortality. has potential to discover cancer in early stages before the onset of symptoms, leading to higher rates of survival. Second, premalignant lesions such as adenomatous polyps, intestinal metaplasia and dysplasia can be discovered and removed with local resection, akin to polypectomies during screening colonoscopies, preventing the development of cancer. Third, EGD discovery and treatment of active Helicobacter pylori (HP) infection of the stomach provides an opportunity for primary prevention of GC.

Detailed description

The primary objective of the study is to evaluate the acceptability and feasibility of EGD-SC. The secondary objectives are: 1. Estimate Median added time needed for EGD at the time of routine screening colonoscopy 2. Estimate the frequencies of adverse events 3. Estimate the percentage of pre-cancer and cancerous lesions including H. pylori infection, chronic atrophic gastritis, IM, dysplasia and GC among this high GC risk population 4. Investigate whether high-risk racial/ethnicity groups have different likelihood of uptake of EGD, and whether the likelihood is associated with patient beliefs, attitudes and knowledge of GC, perceptions of risk, motivators and barriers, and sociocultural factors, as well as patient preference and satisfaction with EGD-SC

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	esophagogastroduodenoscopy (EGD)	After colonoscopy, the patient will undergo the EGD at which time biopsy specimens will be obtained. Participants will also be provided with a home stool collection kit which they can bring to the endoscopy visit or mail back. Satisfaction questions will be administered 3-7 days after EGD-SC

Timeline

• Start date: 2023-02-08
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2022-10-04
• Last updated: 2023-09-21

Locations

2 sites across 1 country: United States