Risk Assessment Evaluation for Identifying Participants at High Risk for Stomach Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Identify as Non-Hispanic White

History of gastric cancer

Known premalignant lesions of the stomach

History of upper endoscopy within 2 years

Trial design

Design model

Sequential

Treatments tested in this trial

  • Biopsy

    Procedure/Surgery

    Undergo tissue biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Breath Test

    Procedure/Surgery

    Undergo H. pylori breath test

  • Esophagogastroduodenoscopy

    Procedure/Surgery

    Undergo EGD

  • Questionnaire Administration

    Other intervention

    Complete questionnaires

Treatment groups

240 Participants
are divided into 3 treatment groups
Group A: Part I (initial risk assessment)Experimental treatment 3 interventions
Group B: Part II, Cohort I (EGD, biopsy)Experimental treatment 3 interventions
Group C: Part II, Cohort II (questionnaires)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
At time of screening up to 3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator