Gastric Cancer
Conditions
Keywords
H.pylori infection, chronic atrophic gastritis
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.
Detailed 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
Interventions
PROCEDUREesophagogastroduodenoscopy (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
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability and feasibility of EGD-SC measured by Linear Scale | Pre-Study Screening Day -30 to day0 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Adverse events (AEs) will be evaluated and graded using the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acceptability and feasibility of EGD-SC measured by Linear Scale | Pre-Study Screening Day -30 to day 0 | Linear Scale eligible for the study. The Wilcoxon signed-rank test will be used to assess the participants responses to EGD. |
Countries
United States
Contacts
Primary ContactHaejin In, MD
Outcome results
None listed