Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05566899

Collaborator

(none)

Enrollment

Locations

Arm

17.1

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Procedure: esophagogastroduodenoscopy (EGD)	Early Phase 1

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Acceptability and feasibility of EGD-SC measured by Linear Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903
2	RWJBarnabas Health	New Brunswick	New Jersey	United States	08903

Sponsors and Collaborators

Rutgers, The State University of New Jersey

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Haejin In, Surgical Oncology Associate Professor of Surgery, Rutgers, The State University of New Jersey

ClinicalTrials.gov Identifier:

NCT05566899

Other Study ID Numbers:

CINJ072211

First Posted:

Oct 4, 2022

Last Update Posted:

Jan 4, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Haejin In, Surgical Oncology Associate Professor of Surgery, Rutgers, The State University of New Jersey

H.pylori infection

chronic atrophic gastritis

Additional relevant MeSH terms:

Stomach Neoplasms

Study Results

No Results Posted as of Jan 4, 2023