NCT04191551 The GAstric Precancerous Conditions Study
| NCT ID | NCT04191551 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Gastric Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2018-07-30 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2018-07-30 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Gastric cancer afflicts 27,000 Americans annually and carries a dismal prognosis. One reason for poor outcomes is late diagnosis, as the majority of gastric cancers in the United States are diagnosed at a relatively advanced stage where curative resection is unlikely. Gastric precursors (such as atrophic gastritis and intestinal metaplasia) are precancerous changes to the stomach mucosa which increases risk for subsequent gastric cancer. The Gastric Precancerous Conditions Study (GAPS) is an observational study of patients at elevated risk for gastric cancer. Investigators seek to recruit patients from endoscopy unit of Stanford Health Care, a large academic network of hospitals and clinics serving Northern California. Investigators will recruit patients who are both symptomatic (e.g. dyspepsia) and asymptomatic (e.g. referred for screening), and individuals both with known precursor lesions (such as intestinal metaplasia) or at high risk for carrying precursor lesions. A component of the study is long-term follow-up of individuals with gastric precursors. This is to understand their risk factors for histologic progression and regression. During both index and subsequent endoscopies, the study team will collect biospecimens (e.g. blood, saliva, gastric tissue).
Eligibility Criteria
Inclusion Criteria: Subjects between the ages of 35 and 84, who are undergoing outpatient endoscopy for the following indications are eligible: abdominal pain, dyspepsia, iron deficiency anemia, Helicobacter assessment, surveillance of suspected or known intestinal metaplasia, evaluation for family history of gastric cancer Exclusion Criteria: * Cannot give consent * Have history of gastric surgery * Have history of solid tumor or bone marrow transplant * Platelet Count \< 70 or international normalized ratio \> 1.5
Contact & Investigator
Robert J Huang, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT04191551 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 84 Years, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04191551 currently recruiting?
Yes, NCT04191551 is actively recruiting participants. Contact the research team at rjhuang@stanford.edu for enrollment information.
Where is the NCT04191551 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT04191551 clinical trial?
NCT04191551 is sponsored by Stanford University. The principal investigator is Robert J Huang, MD at Stanford University. The trial plans to enroll 600 participants.
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