Pilot Study of Stomach Cancer Early Detection and Prevention with Endoscopy (Pilot-SCREEN).
Primary Objective:
The primary objective of the study is to evaluate the acceptability and feasibility of EGD SC.
Secondary Objectives:
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 the frequencies of 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.
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Haejin In
- Principal Investigator
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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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