UC Davis Cohort of Pre-Malignant and Malignant Gastro-Intestinal DisEases Study

N/AEnrolling By InvitationNCT05021029

University of California, Davis1,000 enrolled

Overview

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.

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. Clinical information will be obtained through electronic medical record review, including pathology findings, diagnosis dates, treatments, endoscopic procedures, and relevant risk factors. Biospecimens will be analyzed using multi-omics technologies, including DNA sequencing, RNA sequencing, proteomics, metabolomics, and metagenomic profiling. Helicobacter pylori screening will also be performed as part of the research program. By integrating longitudinal clinical data, epidemiologic information, and molecular profiling, this study seeks to improve risk stratification and inform future prevention, surveillance, and early detection strategies for gastric cancer.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Intestinal Metaplasia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. UCDHS patients 2. Of all races/ethnicities 3. Diagnosed with premalignant conditions such as chronic gastritis, atrophic gastritis, autoimmune gastritis, gastric intestinal metaplasia, gastric intestinal dysplasia or gastic polyps 4. During the last 5 years and current years to come (2015-2030) 5. Some participants may be scheduled for endoscopy Exclusion Criteria: * We will not include children (anyone under the age of 18), individuals unable to consent, pregnant women, or prisoners.

Outcomes

Primary Outcomes

Pre-malignant progression

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

Time frame: Baseline, and yearly for 5 years.

Secondary Outcomes

Recruitment response rates

Review number of patients response rates who donated full/partial biospecimen samples.

Time frame: Baseline and yearly for 5 years