Clinical trial · Interventional
Risk Assessment Evaluation for Identifying Participants at High Risk for Stomach Cancer
OUR Stomach Health Project: A Pilot Study to Evaluate the Feasibility of Stomach Cancer Risk Assessment for Early Detection and Secondary Prevention
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Carcinoma | Gastric Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Breath Test | Procedure | — | UNRESOLVED |
| Esophagogastroduodenoscopy | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part I (initial risk assessment)
- description
- Participants complete questionnaires, undergo collection of a blood sample, and undergo an H. pylori breath test for gastric cancer risk assessment at baseline.
- interventionNames
- Procedure: Biospecimen Collection
- Procedure: Breath Test
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Part II, Cohort I (EGD, biopsy)
- description
- Participants may undergo EGD with possible tissue biopsy within 3 months of baseline risk assessment and complete questionnaires annually up to 3 years.
- interventionNames
- Procedure: Biopsy
- Procedure: Esophagogastroduodenoscopy
- Other: Questionnaire Administration
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available