Recruiting

Endoscopy

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05566899

Conditions

Gastric Cancer

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

esophagogastroduodenoscopy (EGD)

Study Details

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

Study ID

NCT05566899

Start date

Feb 8, 2023

Status verified date

Sep, 2023

Completion date

Aug 1, 2024

Anticipated

Primary completion date

Aug 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

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

Primary outcome measure

  • Acceptability and feasibility of EGD-SC measured by Linear Scale [ Time Frame: Pre-Study Screening Day -30 to day0 ]

Central Contacts and Locations

Central contacts

Haejin In, MD

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

Locations

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Haejin In, MD

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

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Sep 21, 2023

Last verified

Sep, 2023

Keywords

  • H.pylori infection
  • chronic atrophic gastritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2023-09-21.