OUR Stomach Health Project: A Pilot Study to Evaluate the Feasibility of Stomach Cancer Risk Assessment for Early Detection and Secondary Prevention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Percentage of screening individuals found to be at high risk for gastric cancer (feasibility)
研究概览
简要总结
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.
详细描述
PRIMARY OBJECTIVE:
I. To determine the feasibility of using community outreach and clinical assessment to identify persons at high risk for gastric cancer.
SECONDARY OBJECTIVES:
I. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Part I (initial risk assessment)
Participants complete questionnaires, undergo collection of a blood sample, and undergo an H. pylori breath test for gastric cancer risk assessment at baseline.
干预措施: Biospecimen Collection (Procedure)
Part I (initial risk assessment)
Participants complete questionnaires, undergo collection of a blood sample, and undergo an H. pylori breath test for gastric cancer risk assessment at baseline.
干预措施: Breath Test (Procedure)
Part I (initial risk assessment)
Participants complete questionnaires, undergo collection of a blood sample, and undergo an H. pylori breath test for gastric cancer risk assessment at baseline.
干预措施: Questionnaire Administration (Other)
Part II, Cohort I (EGD, biopsy)
Participants may undergo EGD with possible tissue biopsy within 3 months of baseline risk assessment and complete questionnaires annually up to 3 years.
干预措施: Biopsy (Procedure)
Part II, Cohort I (EGD, biopsy)
Participants may undergo EGD with possible tissue biopsy within 3 months of baseline risk assessment and complete questionnaires annually up to 3 years.
干预措施: Esophagogastroduodenoscopy (Procedure)
Part II, Cohort I (EGD, biopsy)
Participants may undergo EGD with possible tissue biopsy within 3 months of baseline risk assessment and complete questionnaires annually up to 3 years.
干预措施: Questionnaire Administration (Other)
Part II, Cohort II (questionnaires)
Participants complete questionnaires for re-assessment annually up to 3 years and may undergo EGD at year 2.
干预措施: Esophagogastroduodenoscopy (Procedure)
Part II, Cohort II (questionnaires)
Participants complete questionnaires for re-assessment annually up to 3 years and may undergo EGD at year 2.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Percentage of screening individuals found to be at high risk for gastric cancer (feasibility)
时间窗: 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).
次要结局
未报告次要终点