5-HIAA in Urine Versus 5-HIAA in Plasma Patients With a Serotonin Producing Neuroendocrine Tumor'

Study Overview
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Brief Summary
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The objective of this observational laboratory study is to measure the correlation between 5-hydroxyindolacetic acid (5-HIAA) in platelet rich plasma and 5-HIAA in 24-hours urine collection in adult patients with a serotonin-producing neuro-endocrine tumor. Plasma and urine of included patients are collected and 5-HIAA values are measured with LCMS-MS and analysed.

Detailed Description
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In midgut NETs serotonin production is most prominent. Patients with NETs producing excessive serotonin can develop carcinoid syndrome. Serotonin is a product of the 'tryptophan pathway'. Serotonin is metabolized in 5-hydroxyindolacetic acid (5-HIAA) and then excreted with urine. 5-HIAA in 24-hour urine collection is one of the parameters used for follow up in patients with a serotonin-producing neuroendocrine tumor. This measurement has some disadvantages; it could be stressful, the collection is not always precisely, furthermore the collection could be problematic, for example in patients with diarrhea. Since October 2013 it is possible, because of a better measurement sensitivity, to measure reliably 5-HIAA in platelet rich plasma (PRP) by isotope-dilution massa-spectrometer (LCMS-MS). Recent publications show that 5-HIAA measured in PRP could have an additive value in diagnosis and follow up of patients with serotonin-producing NET. Objective: The primary objective is to measure the correlation between 5-HIAA in PRP and 5-HIAA in 24-hours urine collection in adult patients with a serotonin-producing neuro-endocrine tumor. Secondary objective is to determine if increase or decrease of 5-HIAA in plasma is associated with disease progression. Study design: This is an observational laboratory study. Plasma and urine of included patients and collected in standard health care, are selected and the 5-HIAA's are measured with LCMS-MS. Also age, sex, diagnosis and clinical course of the patients will be collected from the medical record. Study population: In this study the investigators will use blood and urine of 60 patients with serotonin-producing neuro-endocrine tumors. Main study parameters/endpoints: The main endpoint of this study is the correlation between 5-HIAA in PRP and 5-HIAA in 24-hour urine collection. Secondary endpoint is the correlation between 5-HIAA in PRP and course of the disease, determined by CT-scan (if applicable).

Official Title
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'5-HIAA in Urine Versus 5-HIAA in Plasma in Patients With a Serotonin Producing Neuroendocrine Tumor'

Conditions
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Neuroendocrine Tumors

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Serotonin in platelets > 5.4 nmol / 10^9 and 5-HIAA in 24-hours urine >3.8 mmol/mol creatinine Adult NET patients (aged ≥ 18 years of age) Blood and urine collection of the patient are collected within four days Patients are allowed to be included more than once. Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the correlation between 5-HIAA in PRP and 5-HIAA in 24-hour urine collection |  | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the course of the disease according to the course of 5-HIAA in plasma | the course of the disease according to the course of 5-HIAA in plasma | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuroendocrine tumors, 5-hydroxyindolacetic acid, serotonin, isotope-dilution massa-spectrometer