Neuroendocrine Tumors Clinical Trial
Official title:
Exploring the Metabolic Profile of Neuroendocrine Tumors
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 |
Verified date | October 2019 |
Source | University Medical Center Groningen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 210 |
Est. completion date | August 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | indol profile; 5-HTP, Serotonin, 5-Hydroxyindolacetic acid, Tryptophan in platelet rich plasma | indol profile in platelet rich plasma | at one visit | |
Secondary | catecholamines; L-DOPA, Dopamine, Norepinephrine, Epinephrine, -Methoxytyramine, Normetanephrine, Metanephrine in platelet rich plasma | catecholamines in platelet rich plasma | at one visit | |
Secondary | indoles and catecholamines; L-DOPA, 5-HTP, Dopamine, Norepinephrine, Epinephrine, 3-Methoxytyramine, Normetanephrine, Metanephrine, Serotonin, 5-Hydroxyindolacetic acid | indoles and catecholamines in urine | at one visit |
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