CarcinomaBANNNCT01398306
Biomarkers for Angiogenesis in Renal Cell Carcinoma and Neuro-endocrine Tumours.
An observational study of Carcinoma and Carcinoma, Renal Cell, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Carcinoma, Renal Cell, Neuroendocrine Tumors
- What is being tested?
- Blood sampling by vena punction.
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2011to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clear cell renal cell carcinoma with metastases and patients with low grade neuroendocrine tumours with metastases.
Who may be able to join
- 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
Who cannot join
- Use of L-dopa or SSRI.
- Patients with a second primary malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Carcinoma, Carcinoma, Renal Cell, Neuroendocrine Tumors, Carcinoid Tumor, Pancreatic Islet Cell Tumors
- Being tested
- Blood sampling by vena punction.
- Keywords
- 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
- Medical subject headings
- Carcinoma, Carcinoma, Renal Cell, Neuroendocrine Tumors, Carcinoid Tumor, Adenoma, Islet Cell, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients with clear cell renal cell carcinoma with metastases. Receives: Other: Blood sampling by vena punction. | |
| Group B | Patients with low grade neuro-endocrine tumours with metastases. Receives: Other: Blood sampling by vena punction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sjoukje F. Oosting, MD, Study chair, University Medical Center GroningenMarloes A.M. Peters, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398306
- Sponsor's protocol ID
- 230520112
- Acronym
- BANN
- Status last verified
- May 2024
- First submitted
- 19 Jul 2011
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for Angiogenesis in Renal Cell Carcinoma and Neuro-endocrine Tumours.
- ClinicalTrials.gov ID
- NCT01398306
- Acronym / sponsor ID
- BANN / 230520112
- Conditions
- Carcinoma, Carcinoma, Renal Cell, Neuroendocrine Tumors, Carcinoid Tumor, Pancreatic Islet Cell Tumors
- Keywords
- Angiogenesis Inhibitors, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Adenocarcinoma, Kidney Neoplasms, Urologic Neoplasms, Urogenital Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Blood sampling by vena punction.Patients with clear cell renal cell carcinoma with metastases. |
| Group B | – | Other: Blood sampling by vena punction.Patients with low grade neuro-endocrine tumours with metastases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clear cell renal cell carcinoma with metastases and patients with low grade neuroendocrine tumours with metastases.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Use of L-dopa or SSRI.
- Patients with a second primary malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Group A, Group B |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sjoukje F. Oosting, MD study chair
University Medical Center Groningen
Marloes A.M. Peters principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma and Carcinoma, Renal Cell, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.