Stomach Neoplasm Clinical Trial
— GEMOfficial title:
The Gastric HormonE BioMarkers of Preneoplastic Lesions (GEM) Study
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).
Status | Not yet recruiting |
Enrollment | 600 |
Est. completion date | September 2, 2024 |
Est. primary completion date | September 2, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | University College, London, University of Copenhagen, University of Oxford |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serologic concentrations of ghrelin, gastrin, pepsinogens and vitamin B12 | Serologic concentrations for patients with atrophic gastritis and intestinal metaplasia will be compared to normal/mild gastritis controls. | Measurements will be made on conclusion of the study, one year after enrollment begins |
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