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Trial Title:
Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy
NCT ID:
NCT05566899
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
H.pylori infection
chronic atrophic gastritis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
esophagogastroduodenoscopy (EGD)
Description:
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
Arm group label:
EGD at time of routine screening colonoscopy
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
Criteria for 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
Gender:
All
Minimum age:
40 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Haejin In, MD
Phone:
732-235-3972
Email:
hi80@cinj.rutgers.edu
Facility:
Name:
RWJBarnabas Health
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Haejin In, MD
Phone:
732-235-3972
Email:
hi80@cinj.rutgers.edu
Start date:
February 8, 2023
Completion date:
August 1, 2024
Lead sponsor:
Agency:
Rutgers, The State University of New Jersey
Agency class:
Other
Source:
Rutgers, The State University of New Jersey
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05566899
