Clinical trial · Observational
The Gastric HormonE BioMarkers of Preneoplastic Lesions Study
The Gastric HormonE BioMarkers of Preneoplastic Lesions (GEM) Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Atrophic Gastritis | — | UNRESOLVED | — |
| Intestinal Metaplasia | — | UNRESOLVED | — |
| Stomach Neoplasm | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Normal/mild gastritis
- description
- Patients enrolled with normal stomach epithelium or mild gastritis
- label
- Chronic atrophic gastritis
- description
- Patients enrolled with chronic atrophic gastritis
- label
- Intestinal metaplasia
- description
- Patients enrolled with intestinal metaplasia
Primary outcomes (1)
- measure
- Serologic concentrations of ghrelin, gastrin, pepsinogens and vitamin B12
- timeFrame
- Measurements will be made on conclusion of the study, one year after enrollment begins
- description
- Serologic concentrations for patients with atrophic gastritis and intestinal metaplasia will be compared to normal/mild gastritis controls.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available