Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06085677
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-17
First Post:
2023-10-10
Brief Title:
The Gastric HormonE BioMarkers of Preneoplastic Lesions Study
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
The Gastric HormonE BioMarkers of Preneoplastic Lesions GEM Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
GEM
Brief Summary:
The goal of the study is to understand whether blood levels of hormones produced or metabolized in the stomach reflect the health of the stomach lining
Specifically the study will determine whether the concentration of ghrelin gastrin pepsinogens and vitamin B12 reflect the condition of the stomach lining Hormone concentrations for people with normalmild gastritis will be compared to people with long-term inflammation of the stomach chronic atrophic gastritis and people with pre-cancerous cellular changes intestinal metaplasia
Specifically the study will determine whether the concentration of ghrelin gastrin pepsinogens and vitamin B12 reflect the condition of the stomach lining Hormone concentrations for people with normalmild gastritis will be compared to people with long-term inflammation of the stomach chronic atrophic gastritis and people with pre-cancerous cellular changes intestinal metaplasia
Detailed Description:
Previously published promising data show that blood levels of ghrelin gastrin vitamin B12 and pepsinogen are each associated with risk of developing stomach cancer These studies used blood bank samples and looked at risk of cancer many decades later This study was designed to explore whether these markers could be useful in a clinical setting for early detection of stomach cancer
The study will recruit at 3 sites over 1 year identifying patients with chronic atrophic gastritis and intestinal metaplasia and those with mild gastritis
Only the patient data which is absolutely necessary for analysis will be collected to include basic demographics relevant medical history and medications These data will be used to analytically account for alternative explanations for variation in blood measurements of ghrelin gastrin pepsinogen and vitamin B12
A one-time venous blood sample will be collected to enable measurement of the markers of interest
The study will recruit at 3 sites over 1 year identifying patients with chronic atrophic gastritis and intestinal metaplasia and those with mild gastritis
Only the patient data which is absolutely necessary for analysis will be collected to include basic demographics relevant medical history and medications These data will be used to analytically account for alternative explanations for variation in blood measurements of ghrelin gastrin pepsinogen and vitamin B12
A one-time venous blood sample will be collected to enable measurement of the markers of interest
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