Glioblastoma MultiformeNCT03225963
Application of Proteome Profiler Antibody Arrays to Find Angiogenetic Predictors in Glioma Paitents.
An observational study of Glioblastoma Multiforme and Angiogenesis, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
Bevacizumab has become the standard of care of recurrent glioblastoma based on promising clinical trial results with with response rates up to 50% and progression-free survival up to 9 months. In our study, we set to find the serum angiogenesis biomarkers of bevacizumab response. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Glioblastoma Multiforme, Angiogenesis
- What is being tested?
- Chemoradiation with temozolomide
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2015to 31 Jul 2018
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obtain peripheral blood pre-chemotherapy, mid-chemoradition and post-chemoraidtion
Who may be able to join
- Age older than 20 year old.
- Glioblastoma patients who will receive chemoradiation treatment.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 407
Weir Chiang You, M.D. PhD, 886-4-23592525 ext. 5602, bigjohnyou@vghtc.gov.tw
About this study
Bevacizumab has become the standard of care of recurrent glioblastoma based on promising clinical trial results with with response rates up to 50% and progression-free survival up to 9 months. In our study, we set to find the serum angiogenesis biomarkers of bevacizumab response.
Read the detailed description
Pre-chemoradiation and post-chemoradiation peripheral blood will be obtained to see if there are some angiogenesis biomarker available for prediction of bevacizumab response later.
- Conditions
- Glioblastoma Multiforme, Angiogenesis
- Being tested
- Chemoradiation with temozolomide
- Keywords
- Glioblastoma, Bevacizumab
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemoradiation with temozolomideRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Response of bevacizumab therapy.
Base on the image after bevacizumab therapy (after recurrence)
Measured: 3 months after bevacizumab therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Aug 2015
- Primary completion31 Jul 2018 (estimated)
- Study completion31 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weir Chiang You, M.D. Ph.D., Study chair, The Institutional Review Board of Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03225963
- Sponsor's protocol ID
- CE15180B
- Status last verified
- Jul 2017
- First submitted
- 19 Jul 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lamszus K, Ulbricht U, Matschke J, Brockmann MA, Fillbrandt R, Westphal M. Levels of soluble vascular endothelial growth factor (VEGF) receptor 1 in astrocytic tumors and its relation to malignancy, vascularity, and VEGF-A. Clin Cancer Res. 2003 Apr;9(4):1399-405.
PubMed 12684411Reynes G, Vila V, Martin M, Parada A, Fleitas T, Reganon E, Martinez-Sales V. Circulating markers of angiogenesis, inflammation, and coagulation in patients with glioblastoma. J Neurooncol. 2011 Mar;102(1):35-41. doi: 10.1007/s11060-010-0290-x. Epub 2010 Jul 6.
PubMed 20607353
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Proteome Profiler Antibody Arrays to Find Angiogenetic Predictors in Glioma Paitents.
- ClinicalTrials.gov ID
- NCT03225963
- Acronym / sponsor ID
- CE15180B
- Conditions
- Glioblastoma Multiforme, Angiogenesis
- Keywords
- Glioblastoma, Bevacizumab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Jul 2018 (estimated)
- Study completion
- 31 Jul 2018 (estimated)
- First posted
- 21 Jul 2017 (actual)
- 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 has become the standard of care of recurrent glioblastoma based on promising clinical trial results with with response rates up to 50% and progression-free survival up to 9 months. In our study, we set to find the serum angiogenesis biomarkers of bevacizumab response.
Detailed description
Pre-chemoradiation and post-chemoradiation peripheral blood will be obtained to see if there are some angiogenesis biomarker available for prediction of bevacizumab response later.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obtain peripheral blood pre-chemotherapy, mid-chemoradition and post-chemoraidtion
Key inclusion criteria (2 listed)
- Age older than 20 year old.
- Glioblastoma patients who will receive chemoradiation treatment.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Chemoradiation with temozolomide | Radiation | – |
Primary outcome
Response of bevacizumab therapy.
Time frame: 3 months after bevacizumab therapy
Base on the image after bevacizumab therapy (after recurrence)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Background: PubMed 12684411Lamszus K, Ulbricht U, Matschke J, Brockmann MA, Fillbrandt R, Westphal M. Levels of soluble vascular endothelial growth factor (VEGF) receptor 1 in astrocytic tumors and its relation to malignancy, vascularity, and VEGF-A. Clin Cancer Res. 2003 Apr;9(4):1399-405.
- Background: PubMed 20607353Reynes G, Vila V, Martin M, Parada A, Fleitas T, Reganon E, Martinez-Sales V. Circulating markers of angiogenesis, inflammation, and coagulation in patients with glioblastoma. J Neurooncol. 2011 Mar;102(1):35-41. doi: 10.1007/s11060-010-0290-x. Epub 2010 Jul 6.
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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.
Weir Chiang You, M.D. Ph.D. study chair
The Institutional Review Board of Taichung Veterans General Hospital
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 Glioblastoma Multiforme and Angiogenesis, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Jul 2017. 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 Taiwan. 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?
Contact Weir Chiang You, M.D. Ph.D. (886-4-23592525 ext. 5602, bigjohnyou@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response of bevacizumab therapy. (time frame: 3 months after bevacizumab therapy). 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 NCT03225963, which also lists 2 linked publications.
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 24 Jul 2017.