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…
ID
Source
Brief title
Condition
- Endocrine neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
In addition, levels of catecholamines and metabolites in these three groups
will be determined.
Background summary
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.
Study 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.
Study 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 burden and risks
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.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for all subjects:
- written informed consent
- age above 18 years
Inclusion criteria for patients with a NET: (one of these)
- histologically proven NET, with or without treatment for the NET
- a diagnosis made by a dedicated NET specialist based on a combination of physical symptoms and signs, imaging and laboratory values.
Inclusion criteria for healthy subjects:
- Matching in age (plus or minus 3 years) and sex with one of the included NET patients.
Data of healthy subjects could also be used from the SERT-study, if the subject meets the criteria mentioned above.
Exclusion criteria
Exclusion criteria for all subjects:
- Use of drugs or food supplements that interact with the serotonin-metabolism; all serotonin re-uptake inhibitors, psychotrophic drugs, (other antidepressants; tricyclic antidepressants, MAO-inhibitors, mirtazapin, bupropion, venlafaxin, duloxetin, anxiolytic, antipsychotic and anticonvulsive drugs).
- Drug abuse in the last 8 weeks.
- Use of >= 14 alcoholic consumptions a week for women.
- Use of >= 21 alcoholic consumptions a week for men.
Exclusion criteria for healthy subjects:
- Having a neuroendocrine tumor or neuroendocrine carcinoma from any grade and location in present or in history.
- Having a malignancy.
- Having an auto-immune disease.
- Having an infection.
- Having renal impairment.
- Use of interferon.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | clinical trials volgt |
| CCMO | NL58164.042.16 |