Biomarkers For Angiogenesis In Renal Cell Carcinoma And Neuro-endocrine Tumours.

Study Overview

Biomarkers for Angiogenesis in Renal Cell Carcinoma and Neuro-endocrine Tumours.

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.

* To analyse the concentration catecholamines in thrombocytes of patients with clear cell renal cell carcinoma and low grade neuroendocrine tumours. * To compare these concentrations with the concentrations catecholamines in thrombocytes of healthy controls. * To analyse the concentration catecholamines in thrombocytes of patients with clear cell renal cell carcinoma and patients with low grade neuroendocrine tumours with and without medication.

Carcinoma
Carcinoma, Renal Cell
Neuroendocrine Tumors
Carcinoid Tumor
Pancreatic Islet Cell Tumors

OTHER: Blood sampling by vena punction.

230520112

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-07-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-05-03
First Submitted that Met QC Criteria 2011-07-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-05-06
First Posted (ACTUAL) 2011-07-20	Results First Posted N/A	Last Verified 2024-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Group A Patients with clear cell renal cell carcinoma with metastases.	OTHER: Blood sampling by vena punction. We obtain 10mL blood of the patients. The blood is obtained twice: once with angiogenesis inhibitors or mTOR inhibitors, and once without.
: Group B Patients with low grade neuro-endocrine tumours with metastases.	OTHER: Blood sampling by vena punction. We obtain 10mL blood of the patients. The blood is obtained twice: once with angiogenesis inhibitors or mTOR inhibitors, and once without.

Participant Group/Arm

Intervention/Treatment

: Group A

Patients with clear cell renal cell carcinoma with metastases.

OTHER: Blood sampling by vena punction.

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

: Group B

Patients with low grade neuro-endocrine tumours with metastases.

OTHER: Blood sampling by vena punction.

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

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Sjoukje F. Oosting, MD, University Medical Center Groningen

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record