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

To establish a prospective cohort of individuals diagnosed with gastric pre-malignant conditions (chronic gastritis, atrophic gastritis, autoimmune gastritis, intestinal metaplasia, intestinal dysplasia) to monitor and study disease progression. The Investigators will like to survey cohort participants for lifestyle behaviors and environmental exposures associated with gastric pre-malignancy and cancer. Analyzing patient biospecimens to identify and characterize host and microbiome biomarkers associated with initiation and progression of gastric pre-malignancies.

Conditions

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

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

  2024

Secondary Outcomes (1)

• Recruitment response rates

  2024

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 (2015-2025)
• 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 and/or gastric biopsy or gastric juices.

MeSH Terms

Conditions

Gastritis, Atrophic

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: CASE CONTROL
• 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, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

US (1)