Molecular and Epidemiological Risk Factors in the Development of Gastric Cancer

The University of Texas System (UT)

Status: Enrolling

Conditions: Gastric Cancer

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04600466

HSC20200467H (Other Identifier)

CTMS# 20-0084

KL2TR002646 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

150 participants in 4 patient groups

Retrospective Non-Hispanics

Description:

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.

Treatment:

Other: Germline Testing

Other: Molecular testing for all participants.

Other: Survey

Retrospective Hispanic

Description:

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.

Treatment:

Other: Germline Testing

Other: Molecular testing for all participants.

Other: Survey

Prospective Non-Hispanic

Description:

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.

Treatment:

Other: Germline Testing

Other: Molecular testing for all participants.

Other: Survey

Prospective Hispanic

Description:

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.

Treatment:

Other: Germline Testing

Other: Molecular testing for all participants.

Other: Survey