Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy

Not Applicable

Recruiting

• Conditions: Gastric Cancer
• Interventions: Procedure: esophagogastroduodenoscopy (EGD)

• Registration Number: NCT05566899
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief 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

Study Timeline

• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-10-02
• Study First Posted: 2022-10-04
• Study Start: 2023-02-08
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-16
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Have provided signed informed consent for the trial
• Aged =40 and =80 years at the time of informed consent
• Not planned to undergo EGD and not had EGD in the last five years
• Planned to undergo colonoscopy
• Half of the recruited subjects will be from high-risk groups
• Willing and able to comply with all aspects of the protocol

Exclusion Criteria

• Persons with total gastrectomy
• Persons with anatomic alteration that precludes EGD
• Medical conditions that substantially increase risks for EGD
• Had EGD in the last five years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EGD at time of routine screening colonoscopy	esophagogastroduodenoscopy (EGD)	This happens on Day 0. Screening for EGD, biopsy samples from esophagus, stomach, gastrointestinal junction, and duodenum AE's.

Primary Outcome Measures

Name	Time	Method
Acceptability and feasibility of EGD-SC measured by Linear Scale	Pre-Study Screening Day -30 to day0	To achieve the goal of assessing feasibility of EDG-SC as well as estimates of effect size needed to determine sample size and power for the planned study, the investigator will collect data on the number of participants contacted, number eligible, and number who agree to EGD-SC.

Secondary Outcome Measures

Name	Time	Method
Number of participants with AE's will be measured by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0	From the time of consent to through five calendar days after screening/treatment	Adverse events (AEs) will be evaluated and graded using the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0

Trial Locations

Locations (2)

RWJBarnabas Health; 🇺🇸 New Brunswick, New Jersey, United States

Rutgers Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States