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

NCT ID: NCT06305169

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 440 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2024-07-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Gastropanel

Intervention Type: 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

Interventions

Gastropanel

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sandwell & West Birmingham Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Nigel Trudgill

Consultant Gastroenterologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sandwell General Hospital

Birmingham, West Midlands, United Kingdom

Countries

United Kingdom

Other Identifiers

1.4

Identifier Type: -

Identifier Source: org_study_id