The Gastric HormonE BioMarkers of Preneoplastic Lesions Study

NCT06085677 | Unknown

• 1 other identifier: 23IC8542
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Stomach Neoplasm; Chronic Atrophic Gastritis; Intestinal Metaplasia

Outcome Measures

Primary Outcomes (1)

• 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.

  Measurements will be made on conclusion of the study, one year after enrollment begins

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead
• University College, London: collaborator
• University of Oxford: collaborator
• University of Copenhagen: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood draw

MeSH Terms

Conditions

Stomach Neoplasms; Gastritis, Atrophic

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastritis; Gastroenteritis

Study Officials

• Gwen Murphy, PhD MPH

  Imperial College Dublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gwen Murphy, PhD MPH

CONTACT

+44 20 7594 3369; g.murphy@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: November 4, 2023
• Primary Completion: September 2, 2024
• Study Completion: September 2, 2024
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share