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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
Sponsor:
Information provided by (Responsible Party):
A.M.E. Walenkamp, University Medical Center Groningen

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.

Condition or disease
Neuroendocrine Tumors

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).


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Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Serotonin




Primary Outcome Measures :
  1. the correlation between 5-HIAA in PRP and 5-HIAA in 24-hour urine collection [ Time Frame: 4 days ]

Secondary Outcome Measures :
  1. 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
blood and urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
60 Plasma and urine collections are used of adult patients with serotonin-producing neuro-endocrine tumors.
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:

Information from the National Library of Medicine

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


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Annemiek Walenkamp, MDPhD University Medical Centre

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Responsible Party: A.M.E. Walenkamp, MD, PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02507908     History of Changes
Other Study ID Numbers: 201500365
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017

Keywords provided by A.M.E. Walenkamp, University Medical Center Groningen:
neuroendocrine tumors
5-hydroxyindolacetic acid
serotonin
isotope-dilution massa-spectrometer

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Serotonin
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs