Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy
NCT ID: NCT05566899
Last Updated: 2023-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2023-02-08
2024-08-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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EGD at time of routine screening colonoscopy
This happens on Day 0. Screening for EGD, biopsy samples from esophagus, stomach, gastrointestinal junction, and duodenum AE's.
esophagogastroduodenoscopy (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
Interventions
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esophagogastroduodenoscopy (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
Eligibility Criteria
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Inclusion Criteria
* 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 anatomic alteration that precludes EGD
* Medical conditions that substantially increase risks for EGD
* Had EGD in the last five years
40 Years
80 Years
ALL
Yes
Sponsors
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Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Haejin In
Surgical Oncology Associate Professor of Surgery
Principal Investigators
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Haejin In, MD
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
RWJBarnabas Health
New Brunswick, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro2022001252
Identifier Type: OTHER
Identifier Source: secondary_id
072211
Identifier Type: -
Identifier Source: org_study_id
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