NCT02507908

Brief Summary

The objective of this observational laboratory study is to measure the correlation between 5-hydroxyindolacetic acid (5-HIAA) in platelet rich plasma and 5-HIAA in 24-hours urine collection in adult patients with a serotonin-producing neuro-endocrine tumor. Plasma and urine of included patients are collected and 5-HIAA values are measured with LCMS-MS and analysed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2015

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

Study Start

First participant enrolled

July 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

1.8 years

First QC Date

July 22, 2015

Last Update Submit

May 3, 2024

Conditions

Neuroendocrine Tumors

Keywords

neuroendocrine tumors5-hydroxyindolacetic acidserotoninisotope-dilution massa-spectrometer

Outcome Measures

Primary Outcomes (1)

  • the correlation between 5-HIAA in PRP and 5-HIAA in 24-hour urine collection

    4 days

Secondary Outcomes (1)

  • the course of the disease according to the course of 5-HIAA in plasma

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

60 Plasma and urine collections are used of adult patients with serotonin-producing neuro-endocrine tumors.

You may qualify if:

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • Serotonin in platelets \> 5.4 nmol / 10\^9 and 5-HIAA in 24-hours urine \>3.8 mmol/mol creatinine
  • Adult NET patients (aged ≥ 18 years of age)
  • Blood and urine collection of the patient are collected within four days Patients are allowed to be included more than once.

You may not qualify if:

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and urine

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

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

Study Officials

  • Annemiek Walenkamp, MDPhD

    University Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 22, 2015

First Posted

July 24, 2015

Study Start

July 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 6, 2024

Record last verified: 2024-05

Locations

NL(1)