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Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy

Rutgers The State University of New Jersey logo

Rutgers The State University of New Jersey

Status

Enrolling

Conditions

Gastric Cancer

Treatments

Procedure: esophagogastroduodenoscopy (EGD)

Study type

Interventional

Funder types

Other

Identifiers

NCT05566899
072211
Pro2022001252 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment

50 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

EGD at time of routine screening colonoscopy
Experimental group
Description:
This happens on Day 0. Screening for EGD, biopsy samples from esophagus, stomach, gastrointestinal junction, and duodenum AE's.
Treatment:
Procedure: esophagogastroduodenoscopy (EGD)

Trial contacts and locations

2

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Central trial contact

Haejin In, MD

Data sourced from clinicaltrials.gov

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