NCT04600466

Molecular and Epidemiological Risk Factors in the Development of Gastric Cancer

Identification of Molecular and Epidemiological Risk Factors in the Development of Gastric Cancer in High-risk Predominantly Hispanic Population

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 129 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This protocol is a single-institution feasibility study to identify the molecular and epidemiological risk factors in the development of gastric cancer in high-risk predominantly Hispanic South Texas population. The study is broken down into two main parts: 1) To identify molecular differences in gastric adenocarcinoma (GAC) between Non-Hispanics and Hispanics, stratified by age, and in benign, pre-malignant, and malignant gastric lesions; and 2) To identify environmental and clinicopathological factors in Hispanics associated with specific molecular changes linked to the development of GAC.

Detailed description

The first part of the study will be accomplished by performing molecular testing on formalin-fixed paraffin-embedded (FFPE) tissues on retrospectively identified patients with GAC. Germline testing will be done on both retrospectively and prospectively identified cohort of patients with diagnosis of GAC. The second part of the study will be accomplished via survey administration on retrospectively and prospectively identified patients with diagnosis of GAC and to test Helicobacter pylori (H. pylori) and Epstein-Barr virus (EBV) infection status, which are known risk factors for the development of GAC, on their FFPE gastric specimen. The data from part 1 and part 2 will be analyzed and correlated. The overall goal of the study is to identify molecular markers and environmental risk factors in GAC unique to Hispanics relative to Non-Hispanics in South Texas, and to define molecular alterations in pre-malignant gastric lesions associated with the development of GAC. The long-term goal is to improve racial disparities by defining prognostic and therapeutic molecular markers and environmental risk factors in Hispanics and ultimately for all patients with GAC. Identification of high-risk molecular markers and environmental factors in the development of GAC will help future deployment of improved prevention and surveillance modalities.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
OTHER	Molecular testing for all participants.	Molecular testing on formalin fixed paraffin-embedded (FFPE) tissues on retrospectively identified patients with gastric adenocarcinoma.
OTHER	Germline Testing	Germline testing will be done on prospectively identified patients and in retrospectively identified patients who are still alive.
OTHER	Survey	Survey will be administered on prospectively identified patients and in retrospectively identified patients who are still alive. Survey will be administered in person or via telephone. The survey in the language of the participants choice (English or Spanish) on sociodemographic information, current and/or prior PPI (proton pump inhibitor), H2 blocker, antibiotic, tobacco, alcohol, and recreational drug use. Questionnaire will include other risk factors for gastric adenocarcinoma such as certain dietary constituents (high salt diet, high consumption of processed meat, etc.) and occupational exposures.

Timeline

• Start date: 2021-01-22
• Primary completion: 2025-06-06
• Completion: 2025-06-06
• First posted: 2020-10-23
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States