This clinical trial evaluates esophagogastroduodenoscopy (EGD) at the time of a routine screening colonoscopy for the early detection of stomach (gastric) cancer in high-risk groups. An EGD uses an endoscope, a lighted camera on the end of a tube, that is passed down the throat to visualize the upper part of the gastrointestinal tract (esophagus, stomach and duodenum) and remove tissue samples to be checked under a microscope for signs of disease. Screening EGD provides three distinct opportunities to decrease gastric cancer disease and death. First, it has potential to discover cancer in early stages before the onset of symptoms, leading to higher rates of survival. Second, pre-cancer lesions (changes that may develop into cancer) can be discovered and removed with local resection, preventing the development of cancer. Third, EGD discovery and treatment of active bacterial (helicobacter pylori) infection of the stomach provides an opportunity for primary prevention of gastric cancer. Adding EGD screening at the time of routine screening colonoscopy may be a safe and effective way to detect pre-cancers and cancers earlier in groups of people who are at high risk for gastric cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT05566899.
Locations matching your search criteria
United States
New Jersey
New Brunswick
Rutgers Cancer Institute of New JerseyStatus: Active
Contact: Haejin In
Phone: 732-235-3972
PRIMARY OBJECTIVE:
I. To evaluate the acceptability and feasibility of EGD-screening colonoscopy (SC).
SECONDARY OBJECTIVES:
I. Estimate median added time needed for EGD at the time of routine screening colonoscopy.
II. Estimate the frequencies of adverse events.
III. Estimate the percentage of pre-cancer and cancerous lesions, including the frequencies of helicobacter pylori (H. pylori) infection, chronic atrophic gastritis, intestinal metaplasia (IM), dysplasia and gastric cancer (GC) among this high GC risk population.
IV. 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.
OUTLINE:
Participants undergo EGD with biopsies from four sites (esophagus, stomach, gastrointestinal junction and duodenum) over 10-15 minutes during a scheduled routine screening colonoscopy on study. Patients also undergo blood sample collection on study.
After completion of study intervention, patients are followed up between days 5-7.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationRutgers Cancer Institute of New Jersey
Principal InvestigatorHaejin In
