GlioblastomaGLIOMICNCT02473484
Search of Protein Biomarkers in Order to Achieve a Molecular Classification of Gliomas
An observational study of Glioblastoma, run by University Hospital, Lille at 1 site in France.
Trial summary
The aim is to classify high grade glioma by matrix-assisted laser desorption/ionization mass spectrometry imaging (MALDI MSI). In order to provide more specific informations for the diagnosis and the prognosis of high grade glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2014to Oct 2017
- 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: high grade glioma
Main inclusion criteria:
- Patients with grade III or IV glioma newly diagnosed with histological evidence
- Surgical indication
- Tumor tissue available at biobank of Lille
- Men and women aged ≥ 18 years
- Informed Consent signed by the patient or his legal representative.
Main exclusion criteria:
- Antecedents of other cancers except basal cell skin cancer or carcinoma in situ of the uterus cervix
- Previous history of brain radiotherapy
- Anti-tumor systemic treatments (chemotherapy or targeted therapy) prior to surgery of glioma
- Genetic disease that may cause brain tumor, potentially radiation-induced tumor
- History of degenerative neurological disease prior to diagnosis
- contraindication to MRI
Trial locations and contacts
1 site in 1 country.
About this study
The aim is to classify high grade glioma by matrix-assisted laser desorption/ionization mass spectrometry imaging (MALDI MSI). In order to provide more specific informations for the diagnosis and the prognosis of high grade glioma.
- Conditions
- Glioblastoma
- Keywords
- High Grade Glioma, Proteomics, MALDI-MSI
- Medical subject headings
- Glioblastoma, Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the correlation between the WHO classification 2007 only established standard diagnostic and classification by mass spectrometry gliomas (lipids, peptides, proteins)
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study start24 Jun 2014
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie Le RHUN, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473484
- Sponsor's protocol ID
- 2013_27
- Other IDs
- 2014-A00185-42
- Acronym
- GLIOMIC
- Status last verified
- Dec 2017
- First submitted
- 12 Jun 2015
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search of Protein Biomarkers in Order to Achieve a Molecular Classification of Gliomas
- ClinicalTrials.gov ID
- NCT02473484
- Acronym / sponsor ID
- GLIOMIC / 2013_27
- Conditions
- Glioblastoma
- Keywords
- High Grade Glioma, Proteomics, MALDI-MSI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 24 Jun 2014 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 16 Jun 2015 (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 aim is to classify high grade glioma by matrix-assisted laser desorption/ionization mass spectrometry imaging (MALDI MSI). In order to provide more specific informations for the diagnosis and the prognosis of high grade glioma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- high grade glioma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the correlation between the WHO classification 2007 only established standard diagnostic and classification by mass spectrometry gliomas (lipids, peptides, proteins)
Time frame: 2.5 years
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 22 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Emilie Le RHUN, MD principal investigator
University Hospital, Lille
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, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Dec 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 France. 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?
To evaluate the correlation between the WHO classification 2007 only established standard diagnostic and classification by mass spectrometry gliomas (lipids, peptides, proteins) (time frame: 2.5 years). 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 22 Dec 2017.