Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05566899
• Other study ID #: 072211
• Secondary ID: Pro2022001252
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: September 2023
• Source: Rutgers, The State University of New Jersey
• Contact: Haejin In, MD
• Phone: 732-235-3972
• Email: hi80[@]cinj.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	RWJBarnabas Health	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability and feasibility of EGD-SC measured by Linear Scale	Linear Scale eligible for the study. The Wilcoxon signed-rank test will be used to assess the participants responses to EGD.	Pre-Study Screening Day -30 to day 0
Primary	Acceptability and feasibility of EGD-SC measured by Linear Scale	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.	Pre-Study Screening Day -30 to day0
Secondary	Number of participants with AE's will be measured by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0	Adverse events (AEs) will be evaluated and graded using 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