Clinical trial NCT02507908: 5-HIAA in Urine Versus 5-HIAA in Plasma Patients With a Serotonin Producing Neuroendocrine Tumor'
Official title: '5-HIAA in Urine Versus 5-HIAA in Plasma in Patients With a Serotonin Producing Neuroendocrine Tumor'
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumors
Keywords: neuroendocrine tumors
5-hydroxyindolacetic acid
serotonin
isotope-dilution massa-spectrometer
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 60 Plasma and urine collections are used of adult patients with serotonin-producing neuro-endocrine tumors.

Brief summary: 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: 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).

Eligibility criteria: 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:

Primary outcomes:
measure: the correlation between 5-HIAA in PRP and 5-HIAA in 24-hour urine collection
timeFrame: 4 days
Secondary outcomes:
measure: the course of the disease according to the course of 5-HIAA in plasma
timeFrame: 1 year
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Centre
name: Annemiek Walenkamp, MDPhD
role: PRINCIPAL_INVESTIGATOR
References: