Trials / Unknown
UnknownNCT06085677
The Gastric HormonE BioMarkers of Preneoplastic Lesions Study
The Gastric HormonE BioMarkers of Preneoplastic Lesions (GEM) Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 600 (estimated)
- Sponsor
- Imperial College London · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
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 normal/mild 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.
Conditions
Timeline
- Start date
- 2023-11-04
- Primary completion
- 2024-09-02
- Completion
- 2024-09-02
- First posted
- 2023-10-17
- Last updated
- 2023-10-17
Source: ClinicalTrials.gov record NCT06085677. Inclusion in this directory is not an endorsement.