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Trial record 44 of 2728 for:    Neuroendocrine Tumors | Neuroendocrine Tumors

The Indol Profile; Exploring the Metabolic Profile of Neuroendocrine Tumors

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ClinicalTrials.gov Identifier: NCT02815969
Recruitment Status : Active, not recruiting
First Posted : June 28, 2016
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
A.M.E. Walenkamp, University Medical Center Groningen

Brief 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.

Condition or disease Intervention/treatment
Neuroendocrine Tumors Other: vena punction

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 210 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exploring the Metabolic Profile of Neuroendocrine Tumors
Study Start Date : September 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy volunteers
If no material of healthy volunteers of the SERT study can be used, then other matched volunteers are asked for a vena punction and urine collection
Other: vena punction
vena punction and urine collection

Patients
Patients are asked for a vena punction and urine collection, if not already done because of medical care.
Other: vena punction
vena punction and urine collection




Primary Outcome Measures :
  1. indol profile; 5-HTP, Serotonin, 5-Hydroxyindolacetic acid, Tryptophan in platelet rich plasma [ Time Frame: at one visit ]
    indol profile in platelet rich plasma


Secondary Outcome Measures :
  1. catecholamines; L-DOPA, Dopamine, Norepinephrine, Epinephrine, -Methoxytyramine, Normetanephrine, Metanephrine in platelet rich plasma [ Time Frame: at one visit ]
    catecholamines in platelet rich plasma

  2. indoles and catecholamines; L-DOPA, 5-HTP, Dopamine, Norepinephrine, Epinephrine, 3-Methoxytyramine, Normetanephrine, Metanephrine, Serotonin, 5-Hydroxyindolacetic acid [ Time Frame: at one visit ]
    indoles and catecholamines in urine



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with foregut NET, patients with a midgut and/or hindgut NET, and healthy volunteers. All patients will be included in one of the groups by a dedicated NET doctor based on a combination of physical symptoms and signs, laboratory values, imaging and histology.
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815969


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: A. M.E. Walenkamp, MD, PhD University Medical Center Groningen

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Responsible Party: A.M.E. Walenkamp, principal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02815969     History of Changes
Other Study ID Numbers: 201600496
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by A.M.E. Walenkamp, University Medical Center Groningen:
neuroendocrine tumors
indol profile
catecholamines
LC-MS/MS

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue