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The Gastric HormonE BioMarkers of Preneoplastic Lesions Study

The Gastric HormonE BioMarkers of Preneoplastic Lesions (GEM) Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06085677
Acronym
GEM
Enrollment
600
Registered
2023-10-17
Start date
2023-11-04
Completion date
2024-09-02
Last updated
2023-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Atrophic Gastritis, Intestinal Metaplasia, Stomach Neoplasm

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 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.

Interventions

None listed

Sponsors

University College, London
CollaboratorOTHER
University of Oxford
CollaboratorOTHER
University of Copenhagen
CollaboratorOTHER
Imperial College London
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

1. Adult patients (18-80 years old) attending upper gastrointestinal endoscopy. 2. Patients able to read and comprehend English. 3. Patients willing and able to provide informed consent. 4. Patients willing and able to provide a venous blood sample.

Exclusion criteria

1. Any individual diagnosed with gastric cancer, or with a history of gastric cancer, prior gastrectomy or bariatric surgery. 2. Any individual with a chronic inflammatory condition of the gastrointestinal tract (Crohn's disease or ulcerative colitis). 3. Once enrolment ceiling is reached for each group, enrolment will close for that group. The study will continue until all groups are complete.

Design outcomes

Primary

MeasureTime frameDescription
Serologic concentrations of ghrelin, gastrin, pepsinogens and vitamin B12Measurements will be made on conclusion of the study, one year after enrollment beginsSerologic concentrations for patients with atrophic gastritis and intestinal metaplasia will be compared to normal/mild gastritis controls.

Contacts

Primary ContactGwen Murphy, PhD MPH
g.murphy@imperial.ac.uk+44 20 7594 3369

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026