5-HIAA in Urine Versus 5-HIAA in Plasma Patients With a Serotonin Producing Neuroendocrine Tumor'
This trial is active, not recruiting.
|Sponsor||University Medical Center Groningen|
|Start date||July 2015|
|End date||October 2017|
|Trial size||60 participants|
|Trial identifier||NCT02507908, 201500365|
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.
the correlation between 5-HIAA in PRP and 5-HIAA in 24-hour urine collection
time frame: 4 days
the course of the disease according to the course of 5-HIAA in plasma
time frame: 1 year
All participants at least 18 years old.
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:
|Official title||'5-HIAA in Urine Versus 5-HIAA in Plasma in Patients With a Serotonin Producing Neuroendocrine Tumor'|
|Principal investigator||Annemiek Walenkamp, MDPhD|
|Description||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).|
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