5-HIAA in Urine Versus 5-HIAA in Plasma Patients With a Serotonin Producing Neuroendocrine Tumor' (5-HIAA)
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|ClinicalTrials.gov Identifier: NCT02507908|
Recruitment Status : Completed
First Posted : July 24, 2015
Last Update Posted : May 5, 2017
|Condition or disease|
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.
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.
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.
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).
|Study Type :||Observational|
|Actual Enrollment :||59 participants|
|Official Title:||'5-HIAA in Urine Versus 5-HIAA in Plasma in Patients With a Serotonin Producing Neuroendocrine Tumor'|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
- 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 ]the course of the disease according to the course of 5-HIAA in plasma
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507908
|University Medical Center Groningen|
|Groningen, Netherlands, 9713 GZ|
|Principal Investigator:||Annemiek Walenkamp, MDPhD||University Medical Centre|