CancerBevaRetNCT00740168
Bevacizumab Treatment and Retinal Vessel Monitoring
An observational study of Cancer, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Bevacizumab might influence the dynamic vessel function after being administered intravenously. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- bevacizumab treatment
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- May 2007to Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients with first bevacizumab treatment
Who may be able to join
- patients who wish and need bevacizumab treatment for underlying disease
Who cannot join
- previous bevacizumab treatment
- known eye disease, eye surgery or eye trauma in history
- myopia >-2.0 dpt
- hyperopia > +2.0 dpt.
- relevant media opacity of the lens
- acute heart disease, ischemic insult, proven coronary heart disease
Show all 12Show fewer
- cardiac arrhythmia or vessel anomalies
- seizure disorder or episode in history
- migraine
- treatment with corticosteroids within 4 weeks before study inclusion
- intake of vasoactive drugs like AT-1 or glitazone
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Retinal Vessel Reaction and Monitoring of Circulation Parameters During Bevacizumab Therapy
Bevacizumab might influence the dynamic vessel function after being administered intravenously.
Read the detailed description
By monitoring different vessel and circulation parameters (e.g. dynamic retinal vessel analyzer) the study will clarify the potential hemodynamic effects of bevacizumab.
- Conditions
- Cancer
- Being tested
- bevacizumab treatment
- Keywords
- bevacizumab, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumab treatmentDrug
Also called Avastin, ATC code: L01XC07, CAS Registry Number:216974-75-3, VEGF-inhibitor
single infusion 10 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| TG | Bevacizumab treatment group with metastasized cancer Receives: Drug: bevacizumab treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter of retinal vessels and dynamic vessel reaction
Measured: Measurements before and after administration
Secondary outcomes (1)
Baroreflex sensitivity, heart frequence variability, reaction to handgrip test
Measured: Measurements before and after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startMay 2007
- Primary completionDec 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tjalf Ziemssen, MD, Principal investigator, Neurological University Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740168
- Sponsor's protocol ID
- B-ANF1
- Acronym
- BevaRet
- Status last verified
- Jan 2016
- First submitted
- 20 Aug 2008
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Reimann M, Folprecht G, Haase R, Trautmann K, Ehninger G, Reichmann H, Ziemssen F, Ziemssen T. Anti-Vascular endothelial growth factor therapy impairs endothelial function of retinal microcirculation in colon cancer patients - an observational study. Exp Transl Stroke Med. 2013 May 13;5(1):7. doi: 10.1186/2040-7378-5-7.
PubMed 23668549
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Retinal Vessel Reaction and Monitoring of Circulation Parameters During Bevacizumab Therapy
- ClinicalTrials.gov ID
- NCT00740168
- Acronym / sponsor ID
- BevaRet / B-ANF1
- Conditions
- Cancer
- Keywords
- bevacizumab, cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 22 Aug 2008 (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.
Bevacizumab might influence the dynamic vessel function after being administered intravenously.
Detailed description
By monitoring different vessel and circulation parameters (e.g. dynamic retinal vessel analyzer) the study will clarify the potential hemodynamic effects of bevacizumab.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TG | – | Drug: bevacizumab treatmentBevacizumab treatment group with metastasized cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients with first bevacizumab treatment
Key inclusion criteria (1 listed)
- patients who wish and need bevacizumab treatment for underlying disease
Key exclusion criteria (12 listed)
- previous bevacizumab treatment
- known eye disease, eye surgery or eye trauma in history
- myopia >-2.0 dpt
- hyperopia > +2.0 dpt.
- relevant media opacity of the lens
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 treatmentAlso: Avastin, ATC code: L01XC07, CAS Registry Number:216974-75-3, VEGF-inhibitorsingle infusion 10 mg/kg | Drug | TG |
Primary outcome
Diameter of retinal vessels and dynamic vessel reaction
Time frame: Measurements before and after administration
1 secondary outcome
Baroreflex sensitivity, heart frequence variability, reaction to handgrip test
Time frame: Measurements before and after administration
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 21 Jan 2016.
- Derived from this study: PubMed 23668549Reimann M, Folprecht G, Haase R, Trautmann K, Ehninger G, Reichmann H, Ziemssen F, Ziemssen T. Anti-Vascular endothelial growth factor therapy impairs endothelial function of retinal microcirculation in colon cancer patients - an observational study. Exp Transl Stroke Med. 2013 May 13;5(1):7. doi: 10.1186/2040-7378-5-7.
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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.
Tjalf Ziemssen, MD principal investigator
Neurological University Clinic
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 Cancer, run by Technische Universität Dresden at 1 site in Germany.
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 1 inclusion and 12 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 21 Jan 2016. 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 Germany. 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?
Diameter of retinal vessels and dynamic vessel reaction (time frame: Measurements before and after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00740168, which also lists 1 linked publication.
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 21 Jan 2016.