Unspecified Adult Solid Tumor, Protocol SpecificNCT00898794
Effect of Bevacizumab and VEGF on Platelet Clustering in Patients Who Are Receiving Bevacizumab for Cancer
An observational study of Unspecified Adult Solid Tumor, Protocol Specific and Unspecified Childhood Solid Tumor, Protocol Specific, run by Kantonsspital Graubünden at 1 site in Switzerland.
Trial summary
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the effect of bevacizumab and VEGF on platelet clustering. PURPOSE: This research study is looking at the effect of bevacizumab and VEGF on platelet clustering in patients with cancer who are receiving… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- bevacizumab, coagulation study and laboratory biomarker analysis
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2007to May 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Receiving bevacizumab for cancer
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Graubuenden
Chur, CH-7000
Roger von Moos, MD, 41-81-256-6646, roger.vonmoos@ksgr.ch
About this study
Official title: Influence of Bevacizumab and VEGF on Platelet Aggregation
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the effect of bevacizumab and VEGF on platelet clustering.
PURPOSE: This research study is looking at the effect of bevacizumab and VEGF on platelet clustering in patients with cancer who are receiving bevacizumab.
Read the detailed description
OBJECTIVES:
- To determine the influence of bevacizumab on platelet aggregation in patients receiving bevacizumab for cancer.
- To determine the influence of VEGF on platelet aggregation.
- To determine the influence of VEGF or bevacizumab on cyclooxygenesis.
- To determine if the sequence of medication plays a role in platelet aggregation.
OUTLINE: Blood samples are collected before and after bevacizumab infusion. Samples are analyzed for measurements of platelet aggregation, coagulation parameters, and endothelial activation (e.g., fibrin fragment F1 and 2, thrombin and antithrombin complex, soluble P-selectin, Von Willebrand factor and factor VIII, tissue factor, and endothelin 1).
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- Being tested
- bevacizumab, coagulation study, laboratory biomarker analysis, platelet aggregation test
- Keywords
- unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabBiological
coagulation studyOther
laboratory biomarker analysisOther
platelet aggregation testOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of bevacizumab on platelet aggregation
Influence of VEGF on platelet aggregation
Influence of VEGF or bevacizumab on cyclooxygenesis
Correlation between medication sequence and platelet aggregation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startOct 2007
- Primary completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- 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
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Graubünden
- Sponsor type
- University, hospital or other
- Investigators
- Roger von Moos, MD, Principal investigator, Kantonsspital Graubünden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898794
- Sponsor's protocol ID
- KSGR-GR-01-07
- Other IDs
- CDR0000631252
- Status last verified
- Jun 2011
- First submitted
- 9 May 2009
- Last updated
- 7 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Bevacizumab and VEGF on Platelet Aggregation
- ClinicalTrials.gov ID
- NCT00898794
- Acronym / sponsor ID
- KSGR-GR-01-07
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- Keywords
- unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kantonsspital GraubündenUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- May 2009 (estimated)
- First posted
- 12 May 2009 (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.
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the effect of bevacizumab and VEGF on platelet clustering.
PURPOSE: This research study is looking at the effect of bevacizumab and VEGF on platelet clustering in patients with cancer who are receiving bevacizumab.
Detailed description
OBJECTIVES:
- To determine the influence of bevacizumab on platelet aggregation in patients receiving bevacizumab for cancer.
- To determine the influence of VEGF on platelet aggregation.
- To determine the influence of VEGF or bevacizumab on cyclooxygenesis.
- To determine if the sequence of medication plays a role in platelet aggregation.
OUTLINE: Blood samples are collected before and after bevacizumab infusion. Samples are analyzed for measurements of platelet aggregation, coagulation parameters, and endothelial activation (e.g., fibrin fragment F1 and 2, thrombin and antithrombin complex, soluble P-selectin, Von Willebrand factor and factor VIII, tissue factor, and endothelin 1).
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| bevacizumab | Biological | – |
| coagulation study | Other | – |
| laboratory biomarker analysis | Other | – |
| platelet aggregation test | Other | – |
Primary outcome
Influence of bevacizumab on platelet aggregation
Influence of VEGF on platelet aggregation
Influence of VEGF or bevacizumab on cyclooxygenesis
Correlation between medication sequence and platelet aggregation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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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.
Roger von Moos, MD principal investigator
Kantonsspital Graubünden
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 Unspecified Adult Solid Tumor, Protocol Specific and Unspecified Childhood Solid Tumor, Protocol Specific, run by Kantonsspital Graubünden at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2013. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of bevacizumab on platelet aggregation. The study lists 4 primary outcomes in all. 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 7 Aug 2013.