The UC Davis Cohort of Pre-Malignant and Malignant GastroIntestinal DisEases (TUMMIE) Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Pre-malignant progression
研究概览
简要总结
The UC Davis Cohort of Pre-Malignant and Malignant GastroIntestinal DisEases (TUMMIE) Study is a prospective longitudinal cohort study designed to improve understanding of the natural history, risk factors, and biological mechanisms underlying gastric pre-malignant conditions and progression to gastric cancer. The study will enroll up to 1,000 adults diagnosed with chronic gastritis, atrophic gastritis, autoimmune gastritis, gastric intestinal metaplasia, gastric dysplasia, or gastric polyps and follow participants for at least five years.
详细描述
The TUMMIE Study will establish a prospective cohort of adults receiving care within the UC Davis Health System who have been diagnosed with gastric pre-malignant conditions. Participants will be identified through electronic health records, healthcare provider referrals, and StudyPages recruitment. Enrolled participants will complete baseline and annual follow-up assessments and may consent to collection of clinical data and biospecimens.
The study aims to:
Establish a prospective cohort of individuals with gastric pre-malignant conditions to monitor neoplastic progression.
Identify host, tissue, and microbiome biomarkers associated with disease initiation and progression.
Characterize the natural history of gastric pre-malignant lesions. Evaluate lifestyle, behavioral, environmental, and social determinants of health associated with gastric cancer risk.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •UCDHS patients
- •Of all races/ethnicities
- •Diagnosed with premalignant conditions such as chronic gastritis, atrophic gastritis, autoimmune gastritis, gastric intestinal metaplasia, gastric intestinal dysplasia or gastic polyps
- •During the last 5 years and current years to come (2015-2030)
- •Some participants may be scheduled for endoscopy
排除标准
- •We will not include children (anyone under the age of 18), individuals unable to consent, pregnant women, or prisoners.
结局指标
主要结局
Pre-malignant progression
时间窗: 2024
Review the number of patients with gastric conditions and any progression to advanced pre-neoplasia/malignancy or cancer and identify and characterize host and microbiome biomarkers associated with initiation and progression of gastric pre-malignancies
Pre-malignant progression
时间窗: Baseline, and yearly for 5 years.
Review the number of patients with gastric conditions and any progression to advanced pre-neoplasia/malignancy or cancer and identify and characterize host and microbiome biomarkers associated with initiation and progression of gastric pre-malignancies
次要结局
- Recruitment response rates(2024)
- Recruitment response rates(Baseline and yearly for 5 years)