Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04600466
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2020-10-09
Brief Title:
Molecular and Epidemiological Risk Factors in the Development of Gastric Cancer
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Identification of Molecular and Epidemiological Risk Factors in the Development of Gastric Cancer in High-risk Predominantly Hispanic Population
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSC20200467H | OTHER | University of Texas Health San Antonio | httpsreporternihgovquickSearchKL2TR002646 |
| KL2TR002646 | NIH | None | None |