Clinical trial NCT04600466: Molecular and Epidemiological Risk Factors in the Development of Gastric Cancer
Official title: Identification of Molecular and Epidemiological Risk Factors in the Development of Gastric Cancer in High-risk Predominantly Hispanic Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: IIMS-UT Health San Antonio
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2020-10-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of gastric adenocarcinoma

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.

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.)

Primary outcomes:
measure: To identify molecular differences in GAC between Non-Hispanics and Hispanics
timeFrame: 5 years
measure: To identify molecular differences in GAC between benign, pre-malignant, and malignant gastric lesions
timeFrame: 5 years
measure: To identify environmental and clinicopathological factors in Hispanics associated with specific molecular changes
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Mays Cancer Center, UT Health San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Mio Kitano, MD
role: PRINCIPAL_INVESTIGATOR
References: