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Trial Title:
The Gastric HormonE BioMarkers of Preneoplastic Lesions Study
NCT ID:
NCT06085677
Condition:
Stomach Neoplasm
Chronic Atrophic Gastritis
Intestinal Metaplasia
Conditions: Official terms:
Stomach Neoplasms
Gastritis
Gastritis, Atrophic
Metaplasia
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Cross-Sectional
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).
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.
Criteria for eligibility:
Study pop:
Patients scheduled for endoscopy within the endoscopy service at participating sites will
be invited to participate in the study and provide a blood sample.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
November 4, 2023
Completion date:
September 2, 2024
Lead sponsor:
Agency:
Imperial College London
Agency class:
Other
Collaborator:
Agency:
University College, London
Agency class:
Other
Collaborator:
Agency:
University of Oxford
Agency class:
Other
Collaborator:
Agency:
University of Copenhagen
Agency class:
Other
Source:
Imperial College London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06085677
