Screening in patients with neuroendocrine tumours (NET) who are malnourished or at risk of malnutrition, using a Malnutrition Universal Screening Tool (MUST)

    Study objectives To evaluate the diagnostic value of established Malnutrition Universal Screening Tool (MUST)1-3 in NET patients
    To achieve management guidelines for NET patients with low, medium and high risk of malnutrition
    Aim to improve the MUST score1-3 of NET patients with use of biomarkers i-e Cg A and bile acid mal absorption tests4-5 i-e faecal elastase, SeHCAT test etc.
    Study design: Cohort Study
    Planned subject number Study: 50 patients with gastrointestinal or pancreatic (GEP) NET: this will include treatment genuine patients and patients who have received an intervention (i.e. surgery and/or treatment with somatostatin therapy). Subgroup analysis between functional and non-functional tumours will be done based on clinical symptoms.
    Controls: patients without NET who are screened for malabsorption in Gastroenterology outpatient clinics (OPCs)
    Schedule of visits and assessments Study patients will be screened as part of pre consultation assessment at outpatient NET clinic visits in order to detect possible risk of malnutrition and to suggest further diagnostic and treatment pathways. Food intake and nutritional data will be collected as part of clinical history taking.

    Validation of MUST score1-3 measurements on another established similar cohort of NET patients
    Diagnosis and main criteria for inclusion and exclusion Subjects with known NET disease will be screened

    Main inclusion criteria: Both genders, signed informed consent. histologically confirmed diagnosis of NET; or strong suspicion of NET using combination of clinical presentation, radiological findings including octreotide or gallium scan; and biomarkers
    Main exclusion criteria: Pregnancy, Unwell patients, Unable to measure height or weight, medications influencing appetite
    Evaluated product: dose/mode of admin/ dosing schedule 1. Body Mass Index
    2. Weight loss
    3. Acute disease effect Score
    Reference therapy: dose/ mode of admin/dosing schedule Stratify patients between Score 0 (low), 1 (medium) or 2 or more (high risk) of malnutrition
    Primary target variables Improvement of sensitivity and accuracy of established nutritional screening test in patients with Neuroendocrine (NET) disease.
    Secondary target variables Establish a modified MUST score specifically for NET patients
    Statistical methods
    Standard statistical methods (ANOVA, GLM, T-tests for subgroup analyses). Sensitivity, specificity and efficacy assessment ( positive predictive value, negative predictive value)

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