- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01398306
Biomarkers for Angiogenesis in Renal Cell Carcinoma and Neuro-endocrine Tumours. (BANN)
May 7, 2012 updated by: S.F. Oosting, University Medical Center Groningen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- 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.
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Groningen, Netherlands, 9700RB
- University Medical Center Groningen
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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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with clear cell renal cell carcinoma with metastases and patients with low grade neuroendocrine tumours with metastases.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Use of L-dopa or SSRI.
- Patients with a second primary malignancy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group A
Patients with clear cell renal cell carcinoma with metastases.
|
We obtain 10mL blood of the patients.
The blood is obtained twice: once with angiogenesis inhibitors or mTOR inhibitors, and once without.
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Group B
Patients with low grade neuro-endocrine tumours with metastases.
|
We obtain 10mL blood of the patients.
The blood is obtained twice: once with angiogenesis inhibitors or mTOR inhibitors, and once without.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: one year
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one year
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Secondary Outcome Measures
Outcome Measure |
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.
Time Frame: one year
|
one year
|
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
- Principal Investigator: Marloes A.M. Peters, University Medical Center Groningen
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 Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
July 19, 2011
First Submitted That Met QC Criteria
July 19, 2011
First Posted (Estimate)
July 20, 2011
Study Record Updates
Last Update Posted (Estimate)
May 8, 2012
Last Update Submitted That Met QC Criteria
May 7, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Kidney Neoplasms
- Pancreatic Diseases
- Adenoma
- Pancreatic Neoplasms
- Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Neuroendocrine Tumors
- Endocrine Gland Neoplasms
- Carcinoid Tumor
- Adenoma, Islet Cell
Other Study ID Numbers
- 230520112
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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