The Gastric HormonE BioMarkers of Preneoplastic Lesions Study (GEM)

October 16, 2023 updated by: Imperial College London

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).

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for endoscopy within the endoscopy service at participating sites will be invited to participate in the study and provide a blood sample.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serologic concentrations of ghrelin, gastrin, pepsinogens and vitamin B12
Time Frame: 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.
Measurements will be made on conclusion of the study, one year after enrollment begins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

University of Copenhagen
University College, London
University of Oxford

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 4, 2023

Primary Completion (Estimated)

September 2, 2024

Study Completion (Estimated)

September 2, 2024

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23IC8542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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