Intestinal MetaplasiaTUMMIENCT05021029
UC Davis Cohort of Pre-Malignant and Malignant Gastro-Intestinal DisEases Study
An observational study of Intestinal Metaplasia and Chronic Gastritis, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Metaplasia, Chronic Gastritis, Atrophic Gastritis
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2021to 31 Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will be selected from University of California Davis Health patients of all races and ethnicities.
Who may be able to join
- 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
Who cannot join
- We will not include children (anyone under the age of 18), individuals unable to consent, pregnant women, or prisoners.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
About this study
Official title: 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.
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.
- Conditions
- Intestinal Metaplasia, Chronic Gastritis, Atrophic Gastritis, Autoimmune Gastritis, Intestinal Dysplasia, Gastric Polyps
- Medical subject headings
- Gastritis, Atrophic, Polyposis, Gastric
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, and yearly for 5 years.
Secondary outcomes (1)
Recruitment response rates
Review number of patients response rates who donated full/partial biospecimen samples.
Measured: Baseline and yearly for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start13 Jul 2021
- Primary completion31 Oct 2030 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal MetaplasiaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis G Carvajal-Carmona, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021029
- Sponsor's protocol ID
- 1614453
- Acronym
- TUMMIE
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2021
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The UC Davis Cohort of Pre-Malignant and Malignant GastroIntestinal DisEases (TUMMIE) Study
- ClinicalTrials.gov ID
- NCT05021029
- Acronym / sponsor ID
- TUMMIE / 1614453
- Conditions
- Intestinal Metaplasia, Chronic Gastritis, Atrophic Gastritis, Autoimmune Gastritis, Intestinal Dysplasia, Gastric Polyps
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 31 Oct 2030 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be selected from University of California Davis Health patients of all races and ethnicities.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- We will not include children (anyone under the age of 18), individuals unable to consent, pregnant women, or prisoners.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Recruitment response rates
Time frame: Baseline and yearly for 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luis G Carvajal-Carmona, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Metaplasia and Chronic Gastritis, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-malignant progression (time frame: Baseline, and yearly for 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.