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Exploring the metabolic profile of neuroendocrine tumors

Completed
Conditions
kanker
neuroendocrine tumor
10014713
Registration Number
NL-OMON43011
Lead Sponsor
niversitair Medisch Centrum Groningen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
210
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.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>In this exploratory study we will measure the indol profile in patients with a<br /><br>foregut NET, mid- and hindgut NET, and healthy volunteers at the time of<br /><br>diagnosis and during follow up and treatment in plasma and urine. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>In addition, levels of catecholamines and metabolites in these three groups<br /><br>will be determined.</p><br>
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