NCT02815969

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

2.9 years

First QC Date

June 21, 2016

Last Update Submit

May 3, 2024

Conditions

Neuroendocrine Tumors

Keywords

neuroendocrine tumorsindol profilecatecholaminesLC-MS/MS

Outcome Measures

Primary Outcomes (1)

  • indol profile; 5-HTP, Serotonin, 5-Hydroxyindolacetic acid, Tryptophan in platelet rich plasma

    indol profile in platelet rich plasma

    at one visit

Secondary Outcomes (2)

  • catecholamines; L-DOPA, Dopamine, Norepinephrine, Epinephrine, -Methoxytyramine, Normetanephrine, Metanephrine in platelet rich plasma

    at one visit

  • indoles and catecholamines; L-DOPA, 5-HTP, Dopamine, Norepinephrine, Epinephrine, 3-Methoxytyramine, Normetanephrine, Metanephrine, Serotonin, 5-Hydroxyindolacetic acid

    at one visit

Study Arms (2)

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

Patients

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

Other: vena punction

Interventions

vena punctionOTHER

vena punction and urine collection

Healthy volunteersPatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • written informed consent
  • age above 18 years
  • 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.
  • \- 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Officials

  • A. M.E. Walenkamp, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 28, 2016

Study Start

September 1, 2016

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

May 6, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)