CClinicalTrials.gg
Enrolling by invitationNCT05021029TUMMIEUpdated Aug 24, 2026

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

An observational study in Intestinal Metaplasia, Chronic Gastritis and Atrophic Gastritis, sponsored by University of California, Davis. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by University of California, Davis · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Intestinal Metaplasia
  • Chronic Gastritis
  • Atrophic Gastritis
  • Autoimmune Gastritis
  • Intestinal Dysplasia
  • Gastric Polyps

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • We will not include children (anyone under the age of 18), individuals unable to consent, pregnant women, or prisoners.
04

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

Primary outcomes

  1. 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

  1. Recruitment response rates

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

    Time frame: Baseline and yearly for 5 years

06

Study locations

1 site
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
07

Registry details

Key details

Study ID
NCT05021029
Lead sponsor
University of California, Davis
Responsible party
Sponsor
First posted
Aug 25, 2021
Start date
Jul 13, 2021
Primary completion
Oct 31, 2030 (estimated)
Completion
Oct 31, 2030 (estimated)
Last update
Aug 24, 2026

Study contacts

Luis G Carvajal-Carmona, PhD
principal investigator · University of California, Davis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion