Measuring the Negative Predictive Value and Specificity of Serum Biomarkers in Gastric Cancer

NCT06305169 | Not Yet Recruiting

• 1 other identifier: 1.4
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

Atrophic gastritis where the cells of the stomach lining change is the single most important precursor condition for gastric cancer. Helicobacter pylori a bacteria which causes infection in the stomach is the most important causative agent of inflammation of the stomach, and subsequent atrophic gastritis. The difficulty with diagnosing patients with gastric cancer is that a lot of patients will suffer from heartburn and pain around the stomach, but very few of those will have gastric cancer. This makes it difficult for GPs to know who to refer for further testing as the current cancer referral criteria are very broad. To reduce the need for invasive diagnostic methods such as endoscopy where a flexible tube with camera is inserted into the gullet and stomach via the mouth, a commercially available blood test (GastroPanel ®) designed to measure the levels of certain key stomach hormones to detect atrophic gastritis has been developed. It is extremely rare for gastric cancer to develop without there first being gastric atrophy. A real word study is needed assess the performance of this blood test in a group of patients referred via an urgent cancer pathway for endoscopy in the UK. Scoring systems have been created to help us triage referrals to endoscopy in those with difficulty swallowing, but no similar score is available for those presenting with other upper abdominal symptoms. By using this blood test as well as collecting patient information we hope to create an improved referral criteria for those needing investigation for gastric cancer.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Measurement of the specificity and negative predictive value of serum biomarkers in gastric cancer

  Gastric serum biomarkers measured by gastropanel will be measured in 400 patients who undergo endoscopy. The research team will measure the specificity and negative predictive value of gastropanel in excluding gastric cancer in patient enrolled into the study.

  12 months

Secondary Outcomes (1)

• Creating a scoring system for patients that warrant urgent endoscopy on the cancer pathway

  3 months

Study Arms (1)

Referrals to endoscopy via the 2 week wait cancer pathway for all indications other than dysphagia

This group will have their serum biomarkers measured by gastropanel a commercially available blood test, along with full blood count and complete a questionnaire.

Diagnostic Test: Gastropanel

Interventions

Gastropanel DIAGNOSTIC_TEST

Gastropanel is a commercially available blood test which given serum levels of pepsinogen I and II and gastrin 17 along with helicobacter pylori infection status

Referrals to endoscopy via the 2 week wait cancer pathway for all indications other than dysphagia

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of those patients referred primarily from their general practice for a cancer pathway endoscopy at the study site.

You may qualify if:

• Patients referred for a 2 week wait cancer pathway endoscopy for the following indications Or Upper abdominal mass consistent with stomach cancer Or Stable upper gastrointestinal bleeding Or
• Aged 55 and over with weight loss and any of the following:
• Upper abdominal pain
• Reflux
• Dyspepsia

You may not qualify if:

• Referrals for therapeutic OGD (e.g. polypectomy, feeding tube insertion)
• Previous gastro-duodenal surgery,
• Any co-morbidity that may impair ability to provide information or give valid consent (e.g. dementia, cerebral vascular disease)

Sponsors & Collaborators

• Sandwell & West Birmingham Hospitals NHS Trust: lead

Study Sites (1)

Sandwell General Hospital

Birmingham, West Midlands, B71 4HJ, United Kingdom

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gastroenterologist

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 12, 2024
• Study Start: April 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)