Gastric CancerNCT05566899
Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy
A study testing esophagogastroduodenoscopy (EGD) in people with Gastric Cancer, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- esophagogastroduodenoscopy (EGD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Feb 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Haejin In, MD, 732-235-3972, hi80@cinj.rutgers.edu
- Not yet recruiting
RWJBarnabas Health
New Brunswick, New Jersey, 08903
Haejin In, MD, 732-235-3972, hi80@cinj.rutgers.edu
About this study
Official title: Primary Objective: The Primary Objective of the Study is to Evaluate the Acceptability and Feasibility of EGD-SC
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.
Read the detailed description
The primary objective of the study is to evaluate the acceptability and feasibility of EGD-SC.
The secondary objectives are:
- Estimate Median added time needed for EGD at the time of routine screening colonoscopy
- Estimate the frequencies of adverse events
- 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
- 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
- Gastric Cancer
- Being tested
- esophagogastroduodenoscopy (EGD)
- Keywords
- H.pylori infection, chronic atrophic gastritis
- Medical subject headings
- Stomach Neoplasms, Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophagogastroduodenoscopy (EGD)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: esophagogastroduodenoscopy (EGD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-Study Screening Day -30 to day0
Secondary outcomes (1)
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
Measured: From the time of consent to through five calendar days after screening/treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start8 Feb 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haejin In, Rutgers, The State University of New Jersey
- Investigators
- Haejin In, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566899
- Sponsor's protocol ID
- 072211
- Other IDs
- Pro2022001252
- Status last verified
- Sep 2023
- First submitted
- 5 Jul 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
In H, De la Torre-Cisneros K, Rana B, Myrthil-Harder P, Adams A, Dalal I, Patel A, Kesavarapu K, Zhou Z, Jhala N, Handorf E, Kinney A. Opportunistic Upper Endoscopy at the Time of Screening Colonoscopy: Feasibility, Acceptability, and Patient Perspectives. Gastro Hep Adv. 2026 Jul 31;5(11):101082. doi: 10.1016/j.gastha.2026.101082. eCollection 2026.
PubMed 42740962
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Objective: The Primary Objective of the Study is to Evaluate the Acceptability and Feasibility of EGD-SC
- ClinicalTrials.gov ID
- NCT05566899
- Acronym / sponsor ID
- 072211
- Conditions
- Gastric Cancer
- Keywords
- H.pylori infection, chronic atrophic gastritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Estimate Median added time needed for EGD at the time of routine screening colonoscopy
- Estimate the frequencies of adverse events
- 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
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| EGD at time of routine screening colonoscopy | Experimental | Procedure: esophagogastroduodenoscopy (EGD)This happens on Day 0. Screening for EGD, biopsy samples from esophagus, stomach, gastrointestinal junction, and duodenum AE's. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | EGD at time of routine screening colonoscopy |
Primary outcome
Acceptability and feasibility of EGD-SC measured by Linear Scale
Time frame: 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.
1 secondary outcome
Number of participants with AE's will be measured by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0
Time frame: From the time of consent to through five calendar days after screening/treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 42740962In H, De la Torre-Cisneros K, Rana B, Myrthil-Harder P, Adams A, Dalal I, Patel A, Kesavarapu K, Zhou Z, Jhala N, Handorf E, Kinney A. Opportunistic Upper Endoscopy at the Time of Screening Colonoscopy: Feasibility, Acceptability, and Patient Perspectives. Gastro Hep Adv. 2026 Jul 31;5(11):101082. doi: 10.1016/j.gastha.2026.101082. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haejin In, MD principal investigator
Rutgers Cancer Institute of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esophagogastroduodenoscopy (EGD) in people with Gastric Cancer, run by Rutgers, The State University of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haejin In, MD (732-235-3972, hi80@cinj.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability and feasibility of EGD-SC measured by Linear Scale (time frame: Pre-Study Screening Day -30 to day0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05566899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.