Gastric CancerNCT04600466
Molecular and Epidemiological Risk Factors in the Development of Gastric Cancer
An observational study of Gastric Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Molecular testing for all participants., Germline Testing and Survey
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2021to 6 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of gastric adenocarcinoma
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, 78229
About this study
Official title: Identification of Molecular and Epidemiological Risk Factors in the Development of Gastric Cancer in High-risk Predominantly Hispanic Population
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.
Read the 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
- Being tested
- Molecular testing for all participants., Germline Testing, Survey
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular testing for all participants.Other
Molecular testing on formalin fixed paraffin-embedded (FFPE) tissues on retrospectively identified patients with gastric adenocarcinoma.
Germline TestingOther
Germline testing will be done on prospectively identified patients and in retrospectively identified patients who are still alive.
SurveyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Molecular testing for all participants.; Other: Germline Testing; Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start22 Jan 2021
- Primary completion6 Jun 2025
- Study completion6 Jun 2025
Why it stopped: PI leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- IIMS-UT Health San Antonio, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Mio Kitano, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600466
- Sponsor's protocol ID
- CTMS# 20-0084
- Other IDs
- KL2TR002646, HSC20200467H
- Status last verified
- Apr 2026
- First submitted
- 9 Oct 2020
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Molecular and Epidemiological Risk Factors in the Development of Gastric Cancer in High-risk Predominantly Hispanic Population
- ClinicalTrials.gov ID
- NCT04600466
- Acronym / sponsor ID
- CTMS# 20-0084
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI leaving institution
- Enrolment
- 129 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- IIMS-UT Health San Antonio, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Retrospective Non-Hispanics | – | Other: Molecular testing for all participants., Other: Germline Testing, Other: SurveyMolecular 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. |
| Retrospective Hispanic | – | Other: Molecular testing for all participants., Other: Germline Testing, Other: SurveyMolecular 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. |
| Prospective Non-Hispanic | – | Other: Molecular testing for all participants., Other: Germline Testing, Other: SurveyMolecular 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. |
| Prospective Hispanic | – | Other: Molecular testing for all participants., Other: Germline Testing, Other: SurveyMolecular 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of gastric adenocarcinoma
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular testing for all participants.Molecular testing on formalin fixed paraffin-embedded (FFPE) tissues on retrospectively identified patients with gastric adenocarcinoma. | Other | Prospective Hispanic, Prospective Non-Hispanic, Retrospective Hispanic, Retrospective Non-Hispanics |
| Germline TestingGermline testing will be done on prospectively identified patients and in retrospectively identified patients who are still alive. | Other | Prospective Hispanic, Prospective Non-Hispanic, Retrospective Hispanic, Retrospective Non-Hispanics |
| SurveySurvey 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. | Other | Prospective Hispanic, Prospective Non-Hispanic, Retrospective Hispanic, Retrospective Non-Hispanics |
Primary outcome
To identify molecular differences in GAC between Non-Hispanics and Hispanics
Time frame: 5 years
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.
To identify molecular differences in GAC between benign, pre-malignant, and malignant gastric lesions
Time frame: 5 years
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.
To identify environmental and clinicopathological factors in Hispanics associated with specific molecular changes
Time frame: 5 years
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.
Results and safety
The study was stopped early (reason given: PI leaving institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mio Kitano, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI leaving institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify molecular differences in GAC between Non-Hispanics and Hispanics (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.