NCT01398306

Brief Summary

The primary objective of this study is to analyse the concentration dopamine and serotonin in thrombocytes of patients with renal cell carcinoma and neuro-endocrine tumours compared to the concentrations of these catecholamines in healthy volunteers. The concentration dopamine and serotonin in thrombocytes with and without medication will also be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2011

Shorter than P25 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

Study Start

First participant enrolled

July 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

July 19, 2011

Last Update Submit

May 3, 2024

Conditions

CarcinomaCarcinoma, Renal CellNeuroendocrine TumorsCarcinoid TumorPancreatic Islet Cell Tumors

Keywords

Angiogenesis InhibitorsNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteKidney DiseasesAngiogenesis Inducing AgentsBiological Markers

Outcome Measures

Primary Outcomes (1)

  • Difference in concentrations DA and 5-HT in thrombocytes of patients with clear cell renal cell carcinoma and healthy controls, and patients with low grade neuroendocrine tumours and healthy controls.

    one year

Secondary Outcomes (1)

  • Difference in concentrations DA and 5-HT in thrombocytes of patients with clear cell renal cell carcinoma and low grade neuroendocrine tumours with and without medication.

    one year

Study Arms (2)

Group A

Patients with clear cell renal cell carcinoma with metastases.

Other: Blood sampling by vena punction.

Group B

Patients with low grade neuro-endocrine tumours with metastases.

Other: Blood sampling by vena punction.

Interventions

Blood sampling by vena punction.OTHER

We obtain 10mL blood of the patients. The blood is obtained twice: once with angiogenesis inhibitors or mTOR inhibitors, and once without.

Group AGroup B

Eligibility Criteria

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

Patients with clear cell renal cell carcinoma with metastases and patients with low grade neuroendocrine tumours with metastases.

You may qualify if:

  • Age 18 years old or older.
  • Patients with clear cell renal cell carcinoma with metastases or patients with a low-grade neuro-endocrine tumor with metastases.
  • Written informed consent

You may not qualify if:

  • Use of L-dopa or SSRI.
  • Patients with a second primary malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

2 x 10mL whole blood, stored as platelet rich and platelet poor plasma.

MeSH Terms

Conditions

CarcinomaCarcinoma, Renal CellNeuroendocrine TumorsCarcinoid TumorAdenoma, Islet CellNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteKidney Diseases

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrologic DiseasesMale Urogenital DiseasesNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueAdenomaPancreatic NeoplasmsDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Sjoukje F. Oosting, MD

    University Medical Center Groningen

    STUDY CHAIR

  • Marloes A.M. Peters

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 20, 2011

Study Start

July 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

May 6, 2024

Record last verified: 2024-05

Locations

NL(1)