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GEM: The Gastric HormonE BioMarkers of Preneoplastic Lesions Study

Sponsor
Imperial College London (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06085677
Collaborator
University College, London (Other), University of Oxford (Other), University of Copenhagen (Other)
600
Enrollment
10
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Gastric HormonE BioMarkers of Preneoplastic Lesions (GEM) Study
    Anticipated Study Start Date :
    Nov 4, 2023
    Anticipated Primary Completion Date :
    Sep 2, 2024
    Anticipated Study Completion Date :
    Sep 2, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Normal/mild gastritis

    Patients enrolled with normal stomach epithelium or mild gastritis
    Chronic atrophic gastritis

    Patients enrolled with chronic atrophic gastritis
    Intestinal metaplasia

    Patients enrolled with intestinal metaplasia

    Outcome Measures

    Primary Outcome Measures

    1. Serologic concentrations of ghrelin, gastrin, pepsinogens and vitamin B12 [Measurements will be made on conclusion of the study, one year after enrollment begins]

      Serologic concentrations for patients with atrophic gastritis and intestinal metaplasia will be compared to normal/mild gastritis controls.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Imperial College London
    • University College, London
    • University of Oxford
    • University of Copenhagen

    Investigators

    • Principal Investigator: Gwen Murphy, PhD MPH, Imperial College Dublin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Imperial College London
    ClinicalTrials.gov Identifier:
    NCT06085677
    Other Study ID Numbers:
    • 23IC8542
    First Posted:
    Oct 17, 2023
    Last Update Posted:
    Oct 17, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Gastritis
    Gastritis, Atrophic
    Metaplasia

    Study Results

    No Results Posted as of Oct 17, 2023