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

Gastric Cancer Clinical Trial

Official title:

Measuring the Negative Predictive Value and Specificity of Serum Biomarkers in Gastric Cancer Along With Creating a Predictive Model for the Identification of Patients That Need Urgent Endoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06305169
• Other study ID #: 1.4
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2024
• Source: Sandwell & West Birmingham Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 440
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
United Kingdom	Sandwell General Hospital	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
Sandwell & West Birmingham Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Creating a scoring system for patients that warrant urgent endoscopy on the cancer pathway	By using the hormone levels detected in the gastropanel blood test along with a blood test to check for anaemia (low red blood count), patient questionnaire looking at symptoms and the patients medical background the research team will use logistic regression analysis to identify factors strongly associated with cancer diagnosis and derive a risk score.	3 months