Clinical trial NCT05566899: Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy
Official title: Primary Objective: The Primary Objective of the Study is to Evaluate the Acceptability and Feasibility of EGD-SC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Keywords: H.pylori infection
chronic atrophic gastritis
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability and feasibility of EGD-SC measured by Linear Scale
timeFrame: Pre-Study Screening Day -30 to day0
Secondary outcomes:
measure: Number of participants with AE's will be measured by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0
timeFrame: From the time of consent to through five calendar days after screening/treatment
Other outcomes:
measure: Acceptability and feasibility of EGD-SC measured by Linear Scale
timeFrame: Pre-Study Screening Day -30 to day 0
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: New Brunswick
country: United States
facility: RWJBarnabas Health
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Haejin In, MD
role: PRINCIPAL_INVESTIGATOR
References: