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| ID | Type | Description | Link |
|---|---|---|---|
| Pro2022001252 | Other Identifier | Rutgers, The State University of New Jersey |
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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.
The primary objective of the study is to evaluate the acceptability and feasibility of EGD-SC.
The secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGD at time of routine screening colonoscopy | Experimental | This happens on Day 0. Screening for EGD, biopsy samples from esophagus, stomach, gastrointestinal junction, and duodenum AE's. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esophagogastroduodenoscopy (EGD) | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability and feasibility of EGD-SC measured by Linear Scale | 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. | Pre-Study Screening Day -30 to day0 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with AE's will be measured by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0 | Adverse events (AEs) will be evaluated and graded using 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability and feasibility of EGD-SC measured by Linear Scale | Linear Scale eligible for the study. The Wilcoxon signed-rank test will be used to assess the participants responses to EGD. | Pre-Study Screening Day -30 to day 0 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haejin In, MD | Contact | 732-235-3972 | hi80@cinj.rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Haejin In, MD | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | Recruiting | New Brunswick | New Jersey | 08903 | United States |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D005757 | Gastritis, Atrophic |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016145 | Endoscopy, Digestive System |
| ID | Term |
|---|---|
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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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.
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| RWJBarnabas Health | Not yet recruiting | New Brunswick | New Jersey | 08903 | United States |
|
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D005756 | Gastritis |
| D005759 | Gastroenteritis |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |