Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy

NCT05566899 | Unknown DMC

• 2 other identifiers: 072211Pro2022001252
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Gastric Cancer

Keywords

H.pylori infection; chronic atrophic gastritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• Acceptability and feasibility of EGD-SC measured by Linear Scale

  Pre-Study Screening Day -30 to day 0

Study Arms (1)

EGD at time of routine screening colonoscopy

EXPERIMENTAL

This happens on Day 0. Screening for EGD, biopsy samples from esophagus, stomach, gastrointestinal junction, and duodenum AE's.

Procedure: esophagogastroduodenoscopy (EGD)

Interventions

esophagogastroduodenoscopy (EGD) PROCEDURE

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

EGD at time of routine screening colonoscopy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (2)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

RECRUITING

RWJBarnabas Health

New Brunswick, New Jersey, 08903, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Gastritis, Atrophic

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastritis; Gastroenteritis

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Haejin In, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haejin In, MD

CONTACT

732-235-3972; hi80@cinj.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Oncology Associate Professor of Surgery

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: October 4, 2022
• Study Start: February 8, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)