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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
S.F. Oosting, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01398306
First received: July 19, 2011
Last updated: May 7, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Carcinoma
Carcinoma, Renal Cell
Neuroendocrine Tumors
Carcinoid Tumor
Pancreatic Islet Cell Tumors
Other: Blood sampling by vena punction.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Biomarkers for Angiogenesis in Renal Cell Carcinoma and Neuro-endocrine Tumours.

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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


Enrollment: 40
Study Start Date: July 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398306

Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Study Chair: Sjoukje F. Oosting, MD University Medical Centre Groningen
Principal Investigator: Marloes A.M. Peters University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: S.F. Oosting, Principal Investigator, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01398306     History of Changes
Other Study ID Numbers: 230520112
Study First Received: July 19, 2011
Last Updated: May 7, 2012
Health Authority: The Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
Angiogenesis Inhibitors
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Angiogenesis Inducing Agents
Biological Markers

Additional relevant MeSH terms:
Carcinoid Tumor
Carcinoma
Carcinoma, Renal Cell
Endocrine Gland Neoplasms
Neoplasms
Neuroendocrine Tumors
Adenocarcinoma
Endocrine System Diseases
Kidney Diseases
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014