Molecular and Epidemiological Risk Factors in the Development of Gastric Cancer

NCT ID: NCT04600466

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-22
• Study Completion Date: 2030-01-22

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Retrospective Non-Hispanics

Molecular testing will be done on formalin fixed paraffin-embeded (FFPE) tissue collected at the time of gastroadenocarcinoma diagnosis and subsequent biopsies. Participants who are alive will be asked to complete a survey and consent to germline testing.

Molecular testing for all participants.

Intervention Type: OTHER

Molecular testing on formalin fixed paraffin-embedded (FFPE) tissues on retrospectively identified patients with gastric adenocarcinoma.

Germline Testing

Intervention Type: OTHER

Germline testing will be done on prospectively identified patients and in retrospectively identified patients who are still alive.

Survey

Intervention Type: OTHER

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.

Retrospective Hispanic

Molecular testing will be done on formalin fixed paraffin-embeded (FFPE) tissue collected at the time of gastroadenocarcinoma diagnosis and subsequent biopsies. Participants who are alive will be asked to complete a survey and consent to germline testing.

Molecular testing for all participants.

Intervention Type: OTHER

Molecular testing on formalin fixed paraffin-embedded (FFPE) tissues on retrospectively identified patients with gastric adenocarcinoma.

Germline Testing

Intervention Type: OTHER

Germline testing will be done on prospectively identified patients and in retrospectively identified patients who are still alive.

Survey

Intervention Type: OTHER

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.

Prospective Non-Hispanic

Molecular testing will be done on formalin fixed paraffin-embeded (FFPE) tissue collected at the time of gastroadenocarcinoma diagnosis and subsequent biopsies. Participants will be asked to complete a survey and consent to germline testing.

Molecular testing for all participants.

Intervention Type: OTHER

Molecular testing on formalin fixed paraffin-embedded (FFPE) tissues on retrospectively identified patients with gastric adenocarcinoma.

Germline Testing

Intervention Type: OTHER

Germline testing will be done on prospectively identified patients and in retrospectively identified patients who are still alive.

Survey

Intervention Type: OTHER

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.

Prospective Hispanic

Molecular testing will be done on formalin fixed paraffin-embeded (FFPE) tissue collected at the time of gastroadenocarcinoma diagnosis and subsequent biopsies. Participants will be asked to complete a survey and consent to germline testing.

Molecular testing for all participants.

Intervention Type: OTHER

Molecular testing on formalin fixed paraffin-embedded (FFPE) tissues on retrospectively identified patients with gastric adenocarcinoma.

Germline Testing

Intervention Type: OTHER

Germline testing will be done on prospectively identified patients and in retrospectively identified patients who are still alive.

Survey

Intervention Type: OTHER

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.

Interventions

Molecular testing for all participants.

Molecular testing on formalin fixed paraffin-embedded (FFPE) tissues on retrospectively identified patients with gastric adenocarcinoma.

Intervention Type: OTHER

Germline Testing

Germline testing will be done on prospectively identified patients and in retrospectively identified patients who are still alive.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged 18 years or older
• Patient with histologically confirmed diagnosis of gastric adenocarcinoma
• Able to understand English or Spanish (only for the prospective cohort)
• GEJ adenocarcinoma Type II (within 1 cm above and 2 cm below the GEJ) and Type III (2-5 cm below the GEJ)
• Hyperplastic polyps

Exclusion Criteria

• Clinically AND genetically confirmed diagnosis of well-established hereditary cancer syndrome
• Gastroesophageal junction (GEJ) adenocarcinoma Type I (1-5 cm above the GEJ) as they are treated as esophageal cancer
• Other benign or malignant histology types (i.e. leiomyoma, gastrointestinal stroma tumors, fundic gland polyps, etc.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IIMS-UT Health San Antonio

UNKNOWN

Sponsor Role: collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Mio Kitano

Clinical Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mio Kitano, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mio Kitano, MD

Role: CONTACT

KITANO@UTHSCSA.EDU

210-450-5990

Facility Contacts

Mio Kitano, MD

Role: primary

kitano@uthscsa.edu

210-450-1000

Other Identifiers

KL2TR002646

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC20200467H

Identifier Type: OTHER

Identifier Source: secondary_id

CTMS# 20-0084

Identifier Type: -

Identifier Source: org_study_id