Stomach NeoplasmGEMNCT06085677
The Gastric HormonE BioMarkers of Preneoplastic Lesions Study
An observational study of Stomach Neoplasm and Chronic Atrophic Gastritis, run by Imperial College London.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stomach Neoplasm, Chronic Atrophic Gastritis, Intestinal Metaplasia
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 4 Nov 2023to 2 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adult patients (18-80 years old) attending upper gastrointestinal endoscopy.
- Patients able to read and comprehend English.
- Patients willing and able to provide informed consent.
- Patients willing and able to provide a venous blood sample.
Who cannot join
- Any individual diagnosed with gastric cancer, or with a history of gastric cancer, prior gastrectomy or bariatric surgery.
- Any individual with a chronic inflammatory condition of the gastrointestinal tract (Crohn's disease or ulcerative colitis).
- Once enrolment ceiling is reached for each group, enrolment will close for that group. The study will continue until all groups are complete.
Trial locations and contacts
No sites are listed yet.
About this study
Official 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).
Read the 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.
- Medical subject headings
- Stomach Neoplasms, Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurements will be made on conclusion of the study, one year after enrollment begins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start4 Nov 2023 (estimated)
- Primary completion2 Sep 2024 (estimated)
- Study completion2 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwen Murphy, PhD MPH, Principal investigator, Imperial College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085677
- Sponsor's protocol ID
- 23IC8542
- Acronym
- GEM
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gastric HormonE BioMarkers of Preneoplastic Lesions (GEM) Study
- ClinicalTrials.gov ID
- NCT06085677
- Acronym / sponsor ID
- GEM / 23IC8542
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- University College, London, University of Oxford, University of Copenhagen
- Study start
- 4 Nov 2023 (estimated)
- Primary completion
- 2 Sep 2024 (estimated)
- Study completion
- 2 Sep 2024 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Adult patients (18-80 years old) attending upper gastrointestinal endoscopy.
- Patients able to read and comprehend English.
- Patients willing and able to provide informed consent.
- Patients willing and able to provide a venous blood sample.
Key exclusion criteria (3 listed)
- Any individual diagnosed with gastric cancer, or with a history of gastric cancer, prior gastrectomy or bariatric surgery.
- Any individual with a chronic inflammatory condition of the gastrointestinal tract (Crohn's disease or ulcerative colitis).
- Once enrolment ceiling is reached for each group, enrolment will close for that group. The study will continue until all groups are complete.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwen Murphy, PhD MPH principal investigator
Imperial College Dublin
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasm and Chronic Atrophic Gastritis, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gwen Murphy, PhD MPH (+44 20 7594 3369, g.murphy@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.