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

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.

Enrolling by invitation

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Key information

Conditions

Intestinal Metaplasia Atrophic Gastritis Autoimmune Gastritis Chronic Gastritis Digestive System Diseases Gastric Polyps Gastritis Gastritis, Atrophic Gastroenteritis Gastrointestinal Diseases Intestinal Dysplasia Polyposis, Gastric Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

We will not include children (anyone under the age of 18), individuals unable to consent, pregnant women, or prisoners.

Treatment and study plan

Primary outcomes

Pre-malignant progression

Time frame: 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

Secondary outcomes

Recruitment response rates

Time frame: Baseline and yearly for 5 years

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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

The UC Davis Cohort of Pre-Malignant and Malignant GastroIntestinal DisEases (TUMMIE) Study

Acronym: TUMMIE

Important dates

Study start: 2021
Primary completion: 2030
Study completion: 2030
First posted: Aug 25, 2021
Registry last updated: Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting