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

NCT05021029 | Enrolling By Invitation

• 1 other identifier: 1614453
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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

  Baseline, and yearly for 5 years.

Secondary Outcomes (1)

• Recruitment response rates

  Baseline and yearly for 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

With patient consents, study team will collect saliva, stool, blood, urine, and/or gastric biopsy or gastric juices.

MeSH Terms

Conditions

Gastritis, Atrophic; Polyposis, Gastric

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Luis G Carvajal-Carmona, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 25, 2021
• Study Start: July 13, 2021
• Primary Completion (Estimated): October 31, 2030
• Study Completion (Estimated): October 31, 2030
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

US (1)