Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy

September 16, 2023 updated by: Haejin In, Rutgers, The State University of New Jersey

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
      • New Brunswick, New Jersey, United States, 08903
        • Not yet recruiting
        • RWJBarnabas Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EGD at time of routine screening colonoscopy
This happens on Day 0. Screening for EGD, biopsy samples from esophagus, stomach, gastrointestinal junction, and duodenum AE's.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability and feasibility of EGD-SC measured by Linear Scale
Time Frame: 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.
Pre-Study Screening Day -30 to day0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with AE's will be measured by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0
Time Frame: 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
From the time of consent to through five calendar days after screening/treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability and feasibility of EGD-SC measured by Linear Scale
Time Frame: Pre-Study Screening Day -30 to day 0
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Investigators

  • Principal Investigator: Haejin In, MD, Rutgers Cancer Institute of New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

July 5, 2022

First Submitted That Met QC Criteria

October 2, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 16, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 072211
  • Pro2022001252 (Other Identifier: Rutgers, The State University of New Jersey)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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