Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02815969 |
| Other study ID # |
201600496 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2016 |
| Est. completion date |
August 2019 |
Study information
| Verified date |
May 2024 |
| Source |
University Medical Center Groningen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This is an observational and exploratory study. Participants will be asked for a blood
collection and a 24- hour collection of urine. The indol profile and levels of catecholamine
and metabolites in PRP, as well as in 24- hour collection of urine will be measured with
LC-MS/MS and analyzed.
Description:
Rationale:
Neuro-endocrine neoplasms are a diverse group of tumors which encompasses heterogeneous
clinical courses. Different NETs are characterized by differences in the synthesis, storage
and release of biogenic amines and their metabolites, e.g. indoles, catecholamines and their
metabolites. Clinical course, prognosis, and treatment are based, among others, on the origin
of the primary tumor. Up to now it was only possible to measure metabolic output of NETs by
serotonin in platelets and 5-HIAA in urine. Due to technical improvements we can now measure
the complete metabolic pathway of serotonin in plasma and urine, which comprises tryptophan,
5-hydroxytryptophan, serotonin and 5-HIAA, the indol profile. Furthermore, levels of
catecholamines and metabolites can now be analyzed in the same sample. This metabolic
profiling could potentially lead to improved diagnosis and characterization of NET patients
and possibly contribute to subsequent treatment consequences.
Therefore, we want to perform an exploratory study to measure the indol profile,
catecholamines and metabolites in patients with NETs of different origin (foregut, midgut and
hindgut) and assess differentiation of their metabolic profile.
Objective:
The aim of this study is to explore the added value of the indol profile in comparison to
serotonin in platelets and 5-HIAA in urine for diagnosis and potentially management of
neuroendocrine tumors including gastrinomas, pNETs and brochopulmonary NETs.
Design:
This is an observational and exploratory study. Participants will be asked for a blood
collection and a 24- hour collection of urine. The indol profile and levels of catecholamine
and metabolites in PRP, as well as in 24- hour collection of urine will be measured with
LC-MS/MS and analyzed.
Study population:
In this study we will use PRP and a 24- hour collection of urine of 70 patients with a
foregut NET, 70 patients with a midgut and/or hindgut NET and 70 matched healthy volunteers.
Healthy volunteers are matched according to age and sex with the included patients. Matched
controls already available in our data bank will be used from the earlier approved SERT study
(NCT 01398306)
Main study parameters:
In this exploratory study we will measure the indol profile in patients with a foregut NET,
mid- and hindgut NET, and healthy volunteers at the time of diagnosis and during follow up
and treatment in plasma and urine.
In addition, levels of catecholamines and metabolites in these three groups will be
determined.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness:
Patients with midgut NET already have blood collections and urinary collection as part of
evaluation of their treatment. Only for patients with foregut NETs and some of the healthy
volunteers one extra blood collection with a vena puncture will be taken. This gives a small
risk of bruising. Furthermore a 24-hours collection of urine will be collected with a
prescription to their diet 48 hours before the collection. This could give some distress.
