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Gastropanel *for early detection of gastric atrophy and gastric cancer

  • Research type

    Research Study

  • Full title

    Gastropanel *for early detection of gastric atrophy and gastric cancer risk

  • IRAS ID

    146285

  • Contact name

    Cinzia Papadia

  • Contact email

    cinzia.papadia@nhs.net

  • Clinicaltrials.gov Identifier

    NCT02114411

  • Duration of Study in the UK

    1 years, 10 months, 7 days

  • Research summary

    Atrophic gastritis (AG) is a condition that is affecting the gastric mucosa with atrophy of the secretory cells producing chloride acid. It is of importance because it may precede the development of gastric cancer (GC). and is therefore recognized as a precancerous lesion
    H. pylori infection is the most important cause of gastritis and subsequent AG. The GastroPanel test (Biohit HealthCare, Helsinki, Finland), is a simple blood test evaluating the four biomarkers specific for testing the ability of the gastric mucosa to produce the digestive enzymes pepsinogen I (P-PGI), and pepsinogen II(P-PGII); gastrin 17 (P-G-17). At the same time the H. pylori antibody (P-HpAb) will be tested to identify if the infection is present. It is the first non-invasive diagnostic tool providing possibilities for detecting the patients at risk for GC and peptic ulcer. A well-designed clinical study is warranted to fully assess the diagnostic accuracy of the GastroPanel examination in detecting AG and other specific gastric conditions associated with an increased risk for GC.
    We are planning to study two hundred and fifty patients (45 years and older, both genders) among the patients with dyspepsia referred for gastroscopy at Homerton University Hospital (London, United Kingdom). During the same visit, all patients are subjected to gastroscopy examination as from NICE guideline for the assessment of dyspepsia. Biopsies from the antrum and corpus will be carried out as usual and examined at the Pathology laboratory of University College of London.
    The principal goal of this clinical trial is to establish the performance of the GastroPanel examination in detecting AG and GC
    This 100% biopsy-confirmed study will calculate the sensitivity (negative predictive value) and the specificity (positive predictive value) of the GastroPanel test.

  • REC name

    East of England - Cambridge South Research Ethics Committee

  • REC reference

    15/EE/0205

  • Date of REC Opinion

    9 Jun 2015

  • REC opinion

    Further Information Favourable Opinion