Gastric CarcinomaNCT06408220
Risk Assessment Evaluation for Identifying Participants at High Risk for Stomach Cancer
A study testing Biopsy, Biospecimen Collection and Breath Test in people with Gastric Carcinoma, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This clinical trial evaluates the usefulness of various risk assessment tests, including Helicobacter pylori (H. pylori) breath testing, questionnaires, and endoscopies for identifying participants at high risk for stomach cancer. H. pylori is a bacteria that causes stomach inflammation and ulcers in the stomach. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Carcinoma
- What is being tested?
- Biopsy, Biospecimen Collection and Breath Test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2024to 9 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Documented informed consent of the participant and/or legally authorized representative
- Assent, when appropriate, will be obtained per institutional guidelines
- Age: ≥ 40 years to ≤ 80 years
- Identify as a racial minority either Asian, Hispanic, or Black American
- Willingness to:
- Provide blood samples and undergo upper endoscopy
Who cannot join
- Identify as Non-Hispanic White
- History of gastric cancer
- Known premalignant lesions of the stomach
- History of upper endoscopy within 2 years
- Women of childbearing potential: Pregnant/ nursing
- An employee who is under the direct/indirect supervision of the principal investigator (PI)/a coinvestigator/the study manager
- A direct study team member
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Yanghee Woo, 626-218-0220, yhwoo@coh.org
Yanghee Woo
About this study
Official title: OUR Stomach Health Project: A Pilot Study to Evaluate the Feasibility of Stomach Cancer Risk Assessment for Early Detection and Secondary Prevention
This clinical trial evaluates the usefulness of various risk assessment tests, including Helicobacter pylori (H. pylori) breath testing, questionnaires, and endoscopies for identifying participants at high risk for stomach cancer. H. pylori is a bacteria that causes stomach inflammation and ulcers in the stomach. People with H. pylori infections may be more likely to develop cancer in the stomach. H. pylori breath testing can help identify the presence of H. pylori infection in a participant and help identify if the participant may be at a higher risk of developing stomach cancer. An endoscopy uses a thin, flexible lighted tube that is inserted inside the esophagus, stomach, and first part of the small intestine. This allows the doctor to see and look for abnormal areas that may need to be biopsied. Risk assessment including H. pylori evaluation, questionnaires, and endoscopies may help identify participants at high risk for stomach cancer and may be a useful screening tool for earlier stomach cancer diagnosis.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility of using community outreach and clinical assessment to identify persons at high risk for gastric cancer.
SECONDARY OBJECTIVES:
- To determine the presence of gastric cancer (GC) associated risk factors amongst the diverse ethnic populations (in greater Orange and Los Angeles Counties).
II. To determine the proportion of high-risk patients who are willing to undergo upper endoscopy.
III. To identify actionable diagnoses on upper endoscopy of high-risk individuals.
EXPLORATORY OBJECTIVE:
- To assess population-based understanding of gastric cancer.
OUTLINE:
PART I: Participants complete questionnaires, undergo collection of a blood sample, and undergo an H. pylori breath test for gastric cancer risk assessment at baseline.
PART II: High-risk participants are assigned to cohort I and non-high risk participants are assigned to cohort II.
COHORT I: Participants may undergo esophagogastroduodenoscopy (EGD) with possible tissue biopsy within 3 months of baseline risk assessment and complete questionnaires annually up to 3 years.
COHORT II: Participants complete questionnaires for re-assessment annually up to 3 years and may undergo EGD at year 2.
Participants are followed up annually for a total of 3 years.
- Conditions
- Gastric Carcinoma
- Being tested
- Biopsy, Biospecimen Collection, Breath Test, Esophagogastroduodenoscopy, Questionnaire Administration
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called BIOPSY_TYPE, Bx
Undergo tissue biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Breath TestProcedure or surgery
Undergo H. pylori breath test
EsophagogastroduodenoscopyProcedure or surgery
Also called EGD
Undergo EGD
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Part I (initial risk assessment) | Experimental | Participants complete questionnaires, undergo collection of a blood sample, and undergo an H. pylori breath test for gastric cancer risk assessment at baseline. Receives: Procedure: Biospecimen Collection; Procedure: Breath Test; Other: Questionnaire Administration |
| Part II, Cohort I (EGD, biopsy) | Experimental | Participants may undergo EGD with possible tissue biopsy within 3 months of baseline risk assessment and complete questionnaires annually up to 3 years. Receives: Procedure: Biopsy; Procedure: Esophagogastroduodenoscopy; Other: Questionnaire Administration |
| Part II, Cohort II (questionnaires) | Active comparator | Participants complete questionnaires for re-assessment annually up to 3 years and may undergo EGD at year 2. Receives: Procedure: Esophagogastroduodenoscopy; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of screening individuals found to be at high risk for gastric cancer (feasibility)
Study feasibility will be defined as ≥ 10% of screened individuals found to be at high risk for gastric cancer. The study will be successful if ≥ 10% of screened individuals (24 of ≤ 240) have a risk score of ≥ 12 or have signs/symptoms that have persisted for ≥ 1 month that are associated with gastric cancer. The reported results will include counts/proportions of screened individuals found to be at high risk for gastric cancer (≥ 12 risk score).
Measured: At time of screening up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start27 Jun 2024
- Primary completion9 Oct 2029 (estimated)
- Study completion9 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Yanghee Woo, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408220
- Sponsor's protocol ID
- 23379
- Other IDs
- NCI-2024-03206, 23379, P30CA033572
- Status last verified
- Mar 2026
- First submitted
- 1 May 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OUR Stomach Health Project: A Pilot Study to Evaluate the Feasibility of Stomach Cancer Risk Assessment for Early Detection and Secondary Prevention
- ClinicalTrials.gov ID
- NCT06408220
- Acronym / sponsor ID
- 23379
- Conditions
- Gastric Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 9 Oct 2029 (estimated)
- Study completion
- 9 Oct 2029 (estimated)
- First posted
- 10 May 2024 (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.
This clinical trial evaluates the usefulness of various risk assessment tests, including Helicobacter pylori (H. pylori) breath testing, questionnaires, and endoscopies for identifying participants at high risk for stomach cancer. H. pylori is a bacteria that causes stomach inflammation and ulcers in the stomach. People with H. pylori infections may be more likely to develop cancer in the stomach. H. pylori breath testing can help identify the presence of H. pylori infection in a participant and help identify if the participant may be at a higher risk of developing stomach cancer. An endoscopy uses a thin, flexible lighted tube that is inserted inside the esophagus, stomach, and first part of the small intestine. This allows the doctor to see and look for abnormal areas that may need to be biopsied. Risk assessment including H. pylori evaluation, questionnaires, and endoscopies may help identify participants at high risk for stomach cancer and may be a useful screening tool for earlier stomach cancer diagnosis.
Detailed description
PRIMARY OBJECTIVE:
- To determine the feasibility of using community outreach and clinical assessment to identify persons at high risk for gastric cancer.
SECONDARY OBJECTIVES:
- To determine the presence of gastric cancer (GC) associated risk factors amongst the diverse ethnic populations (in greater Orange and Los Angeles Counties).
II. To determine the proportion of high-risk patients who are willing to undergo upper endoscopy.
III. To identify actionable diagnoses on upper endoscopy of high-risk individuals.
EXPLORATORY OBJECTIVE:
- To assess population-based understanding of gastric cancer.
OUTLINE:
PART I: Participants complete questionnaires, undergo collection of a blood sample, and undergo an H. pylori breath test for gastric cancer risk assessment at baseline.
PART II: High-risk participants are assigned to cohort I and non-high risk participants are assigned to cohort II.
COHORT I: Participants may undergo esophagogastroduodenoscopy (EGD) with possible tissue biopsy within 3 months of baseline risk assessment and complete questionnaires annually up to 3 years.
COHORT II: Participants complete questionnaires for re-assessment annually up to 3 years and may undergo EGD at year 2.
Participants are followed up annually for a total of 3 years.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part I (initial risk assessment) | Experimental | Procedure: Biospecimen Collection, Procedure: Breath Test, Other: Questionnaire AdministrationParticipants complete questionnaires, undergo collection of a blood sample, and undergo an H. pylori breath test for gastric cancer risk assessment at baseline. |
| Part II, Cohort I (EGD, biopsy) | Experimental | Procedure: Biopsy, Procedure: Esophagogastroduodenoscopy, Other: Questionnaire AdministrationParticipants may undergo EGD with possible tissue biopsy within 3 months of baseline risk assessment and complete questionnaires annually up to 3 years. |
| Part II, Cohort II (questionnaires) | Active comparator | Procedure: Esophagogastroduodenoscopy, Other: Questionnaire AdministrationParticipants complete questionnaires for re-assessment annually up to 3 years and may undergo EGD at year 2. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented informed consent of the participant and/or legally authorized representative
- Age: ≥ 40 years to ≤ 80 years
- Identify as a racial minority either Asian, Hispanic, or Black American
- Willingness to:
Key exclusion criteria (7 listed)
- Identify as Non-Hispanic White
- History of gastric cancer
- Known premalignant lesions of the stomach
- History of upper endoscopy within 2 years
- Women of childbearing potential: Pregnant/ nursing
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 |
|---|---|---|
| BiopsyAlso: BIOPSY_TYPE, BxUndergo tissue biopsy | Procedure or surgery | Part II, Cohort I (EGD, biopsy) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Part I (initial risk assessment) |
| Breath TestUndergo H. pylori breath test | Procedure or surgery | Part I (initial risk assessment) |
| EsophagogastroduodenoscopyAlso: EGDUndergo EGD | Procedure or surgery | Part II, Cohort I (EGD, biopsy), Part II, Cohort II (questionnaires) |
| Questionnaire AdministrationComplete questionnaires | Other | Part I (initial risk assessment), Part II, Cohort I (EGD, biopsy), Part II, Cohort II (questionnaires) |
Primary outcome
Percentage of screening individuals found to be at high risk for gastric cancer (feasibility)
Time frame: At time of screening up to 3 years
Study feasibility will be defined as ≥ 10% of screened individuals found to be at high risk for gastric cancer. The study will be successful if ≥ 10% of screened individuals (24 of ≤ 240) have a risk score of ≥ 12 or have signs/symptoms that have persisted for ≥ 1 month that are associated with gastric cancer. The reported results will include counts/proportions of screened individuals found to be at high risk for gastric cancer (≥ 12 risk score).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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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.
Yanghee Woo principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy, Biospecimen Collection and Breath Test in people with Gastric Carcinoma, run by City of Hope Medical Center at 1 site 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 7 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: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of screening individuals found to be at high risk for gastric cancer (feasibility) (time frame: At time of screening up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2026.