Ignite Creation Date:
2024-05-06 @ 7:17 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02507908
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2015-07-22
Brief Title:
5-HIAA in Urine Versus 5-HIAA in Plasma Patients With a Serotonin Producing Neuroendocrine Tumor
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
5-HIAA in Urine Versus 5-HIAA in Plasma in Patients With a Serotonin Producing Neuroendocrine Tumor
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
5-HIAA
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-HIAAs 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 parametersendpoints
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
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-HIAAs 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 parametersendpoints
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None