Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy
Primary Purpose
Gastric Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
esophagogastroduodenoscopy (EGD)
Sponsored by
About this trial
This is an interventional prevention trial for Gastric Cancer focused on measuring H.pylori infection, chronic atrophic gastritis
Eligibility Criteria
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
Sites / Locations
- Rutgers Cancer Institute of New JerseyRecruiting
- RWJBarnabas Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EGD at time of routine screening colonoscopy
Arm Description
This happens on Day 0. Screening for EGD, biopsy samples from esophagus, stomach, gastrointestinal junction, and duodenum AE's.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05566899
First Posted
July 5, 2022
Last Updated
September 16, 2023
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT05566899
Brief Title
Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy
Official Title
Primary Objective: The Primary Objective of the Study is to Evaluate the Acceptability and Feasibility of EGD-SC
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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:
Estimate Median added time needed for EGD at the time of routine screening colonoscopy
Estimate the frequencies of adverse events
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
H.pylori infection, chronic atrophic gastritis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single-center, open label pilot study that will evaluate the acceptability and feasibility of EGD at time of routine screening colonoscopy (EGD-SC). The Pre-Study Screening is day -30 to day 0; EDG at time of routine screening colonoscopy and follow-up day five to seven.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EGD at time of routine screening colonoscopy
Arm Type
Experimental
Arm Description
This happens on Day 0. Screening for EGD, biopsy samples from esophagus, stomach, gastrointestinal junction, and duodenum AE's.
Intervention Type
Procedure
Intervention Name(s)
esophagogastroduodenoscopy (EGD)
Intervention Description
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
Primary Outcome Measure Information:
Title
Acceptability and feasibility of EGD-SC measured by Linear Scale
Description
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.
Time Frame
Pre-Study Screening Day -30 to day0
Secondary Outcome Measure Information:
Title
Number of participants with AE's will be measured by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0
Description
Adverse events (AEs) will be evaluated and graded using 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
Other Pre-specified Outcome Measures:
Title
Acceptability and feasibility of EGD-SC measured by Linear Scale
Description
Linear Scale eligible for the study. The Wilcoxon signed-rank test will be used to assess the participants responses to EGD.
Time Frame
Pre-Study Screening Day -30 to day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haejin In, MD
Phone
732-235-3972
Email
hi80@cinj.rutgers.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haejin In, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haejin In, MD
Phone
732-235-3972
Email
hi80@cinj.rutgers.edu
Facility Name
RWJBarnabas Health
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haejin In, MD
Phone
732-235-3972
Email
hi80@cinj.rutgers.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy
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