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

August 21, 2026 updated by: University of California, Davis

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

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

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 (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Sacramento, California, United States, 95817
    - University of California Davis Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Study population will be selected from University of California Davis Health patients of all races and ethnicities.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Control
Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, and yearly for 5 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment response rates Time Frame: Baseline and yearly for 5 years	Review number of patients response rates who donated full/partial biospecimen samples.	Baseline and yearly for 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

Principal Investigator: Luis G Carvajal-Carmona, PhD, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2021

Primary Completion (Estimated)

October 31, 2030

Study Completion (Estimated)

October 31, 2030

Study Registration Dates

First Submitted

August 19, 2021

First Submitted That Met QC Criteria