GliomaNCT00137488
Angiogenic Profile and Non-invasive Imaging May Predict Tumor Progression of High Risk Group Low Grade Glioma (LGG)
An observational study of Glioma, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
The low grade glioma (LGG) is a type of brain tumor which is generally more common in younger age group patients. Most patients with LGG undergo surgery which is mostly incomplete due to concern about loss of function. This is an incurable disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- imaging and angiogenic profiles
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2005to Dec 2007
- 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 referred to Cross Cancer Institute between 2004 and 2005
Who may be able to join
- Greater than 18 years of age
- Brain tumor with no contrast enhancement on conventional MRI and confirmed histological of LGG
- No adjustment treatment
- Consent to participate in study
- No contra-indication for dynamic contrast-enhanced (DCE)-MRI
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The low grade glioma (LGG) is a type of brain tumor which is generally more common in younger age group patients. Most patients with LGG undergo surgery which is mostly incomplete due to concern about loss of function. This is an incurable disease. More than half of these patients progress to a higher grade with a worse outcome within five years of their diagnosis and only one-third survive for up to ten years. Post-operative radiation treatment improves local control without survival advantage. Efforts are being made without great success to select the patients with a higher risk of progression based on physical characteristics and histological features.
Tumor vascularity is thought to be the key element in tumor progression. Tremendous progress has been made in functional imaging by using magnetic resonance imaging (MRI) 3-Tesla (3T) and in biotechnology which can be used to investigate angiogenic gene profiles in order to identify gene signature for these tumors. In this study the investigators are proposing that patients of LGG with a higher risk of tumor progression may be selected by functional imaging and angiogenic profiles. These higher risk patients may be candidates for post-operative radiation in the future with a potential survival benefit.
Read the detailed description
Summary: Comprehensive analysis of the angiogenesis-related gene expression profiles and tumor perfusion of patients with LGG will provide a novel understanding of subgroup (low and high-risk) of LGG. Thus, this study will allow identifying clinically relevant factors predictive for tumor progression and to select patients in high-risk group for adjuvant radiation therapy.
- Conditions
- Glioma
- Being tested
- imaging and angiogenic profiles
- Keywords
- non-enhancing lesion, low grade glioma, high risk group selection
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imaging and angiogenic profilesDevice
Image tumor angiogenesis by DCE-MRI using 1.5- or 3-T MRI instruments (13,14,15) pre-and postoperatively (before biopsy or surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startNov 2005
- Primary completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bassam Abdulkarim, MD, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137488
- Sponsor's protocol ID
- CNS-09-0024/ethics 21656
- Status last verified
- Apr 2012
- First submitted
- 26 Aug 2005
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiogenic Profile and Non-invasive Imaging May Predict Tumor Progression of High Risk Group Low Grade Glioma (LGG)
- ClinicalTrials.gov ID
- NCT00137488
- Acronym / sponsor ID
- CNS-09-0024/ethics 21656
- Conditions
- Glioma
- Keywords
- non-enhancing lesion, low grade glioma, high risk group selection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Dec 2007 (actual)
- First posted
- 30 Aug 2005 (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 low grade glioma (LGG) is a type of brain tumor which is generally more common in younger age group patients. Most patients with LGG undergo surgery which is mostly incomplete due to concern about loss of function. This is an incurable disease. More than half of these patients progress to a higher grade with a worse outcome within five years of their diagnosis and only one-third survive for up to ten years. Post-operative radiation treatment improves local control without survival advantage. Efforts are being made without great success to select the patients with a higher risk of progression based on physical characteristics and histological features.
Tumor vascularity is thought to be the key element in tumor progression. Tremendous progress has been made in functional imaging by using magnetic resonance imaging (MRI) 3-Tesla (3T) and in biotechnology which can be used to investigate angiogenic gene profiles in order to identify gene signature for these tumors. In this study the investigators are proposing that patients of LGG with a higher risk of tumor progression may be selected by functional imaging and angiogenic profiles. These higher risk patients may be candidates for post-operative radiation in the future with a potential survival benefit.
Detailed description
Summary: Comprehensive analysis of the angiogenesis-related gene expression profiles and tumor perfusion of patients with LGG will provide a novel understanding of subgroup (low and high-risk) of LGG. Thus, this study will allow identifying clinically relevant factors predictive for tumor progression and to select patients in high-risk group for adjuvant radiation therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients referred to Cross Cancer Institute between 2004 and 2005
Key inclusion criteria (5 listed)
- Greater than 18 years of age
- Brain tumor with no contrast enhancement on conventional MRI and confirmed histological of LGG
- No adjustment treatment
- Consent to participate in study
- No contra-indication for dynamic contrast-enhanced (DCE)-MRI
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| imaging and angiogenic profilesImage tumor angiogenesis by DCE-MRI using 1.5- or 3-T MRI instruments (13,14,15) pre-and postoperatively (before biopsy or surgery). | Device | – |
Primary outcome
Not reported in the source record.
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 26 Feb 2016.
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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.
Bassam Abdulkarim, MD principal investigator
AHS Cancer Control Alberta
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 Glioma, run by AHS Cancer Control Alberta at 1 site in Canada.
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 5 inclusion and 0 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 26 Feb 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 Canada. 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.
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 26 Feb 2016.