Molecular and Epidemiological Risk Factors in the Development of Gastric Cancer

NCT04600466 | Terminated DMC

• 3 other identifiers: CTMS# 20-0084KL2TR002646HSC20200467H
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (3)

• To identify molecular differences in GAC between Non-Hispanics and Hispanics

  DNA from archived FFPE gastric cancer tissue from patients with diagnosis of GAC will be analyzed for the top 25 mutated genes identified in The Cancer Genome Atlas. The results will be compared and analyzed between Hispanics and non-Hispanics. In addition, germline testing using a 156 gene panel using saliva will be performs on patients with GAC and compared between Hispanics and non-Hispanics. Difference in somatic and germline mutations will be analyzed in patients with GAC between Hispanics and non-Hispanics.

  5 years

• To identify molecular differences in GAC between benign, pre-malignant, and malignant gastric lesions

  Archived FFPE slides will be separated into malignant, normal, and pre-malignant sections after histopathology review. These include normal or pre-malignant adjacent tissue from GAC specimen or from prior gastric biopsy specimen. FFPE samples will be stratified into 4 main groups: 1) normal/superficial gastritis (SG); 2) atrophic gastritis (AG)/intestinal metaplasia (IM); 3) dysplasia; and 4) gastric adenocarcinoma (GCA). Top genes among the 25 analyzed in Outcome 1 will be studied on 50 benign and 100 pre-malignant samples and compared to the results from GAC samples from Outcome 1.

  5 years

• To identify environmental and clinicopathological factors in Hispanics associated with specific molecular changes

  A comprehensive survey will be administered to patients with diagnosis of GAC retrospectively (to those who are still alive) and prospectively to query their anthropomorphic data, medical co-morbidities, sociodemographic information, dietary constituents, and exposures to known risk factors in the development of GAC. FFPE with gastric cancer tissue will be tested for EBV and H. pylori retrospectively and prospectively to test for prior exposure to these infections that are known risk factors for GAC.

  5 years

Study Arms (4)

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.

Other: Molecular testing for all participants.; Other: Germline Testing; Other: Survey

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.

Other: Molecular testing for all participants.; Other: Germline Testing; Other: Survey

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.

Other: Molecular testing for all participants.; Other: Germline Testing; Other: Survey

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.

Other: Molecular testing for all participants.; Other: Germline Testing; Other: Survey

Interventions

Molecular testing for all participants. OTHER

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

Prospective Hispanic; Prospective Non-Hispanic; Retrospective Hispanic; Retrospective Non-Hispanics

Germline Testing OTHER

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

Prospective Hispanic; Prospective Non-Hispanic; Retrospective Hispanic; Retrospective Non-Hispanics

Survey 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; Prospective Non-Hispanic; Retrospective Hispanic; Retrospective Non-Hispanics

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

Patients with diagnosis of gastric adenocarcinoma

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• IIMS-UT Health San Antonio: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

FFPE from gastric biopsy will be processed for molecular testing and retained for further testing

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Molecular Diagnostic Techniques; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mio Kitano, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 23, 2020
• Study Start: January 22, 2021
• Primary Completion: June 6, 2025
• Study Completion: June 6, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)