OligodendrogliomaPROGLIONCT04843085
Proteomic Characterization of Aggressive Oligodendrogliomas
An observational study of Oligodendroglioma, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Oligodendrogliomas represent a distinct subgroup of adult gliomas characterized by specific molecular alterations (1p/19q codeletion, mutations of IDH, TERT promoter, CIC, FUBP1). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oligodendroglioma
- What is being tested?
- Proteomic analysis
- How many people
- 120 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Sep 2020to Sep 2023
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: samples of patients with oligodendrolioma, astrocytoma, glioblastoma and normal brain available in the POLA network biobank or the OncoNeuroTek tumor bank (Institut du Cerveau et de la Moelle Épinière)
Who may be able to join
- - transcriptomic (microarray) data available or possible to obtain them,
- methylation (450K) data available or possible to obtain them,
- genomic (SNP array) data available or possible to obtain them,
- sufficient material for proteomic analysis (frozen tumor samples)
Who cannot join
- opposed patients
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Groupement Hospitalier Est HCL
Bron
François Ducray, MD, 04 72 35 78 06, francois.ducray@chu-lyon.fr
- Not yet recruiting
Institut du Cerveau et de la Moelle
Paris
About this study
Oligodendrogliomas represent a distinct subgroup of adult gliomas characterized by specific molecular alterations (1p/19q codeletion, mutations of IDH, TERT promoter, CIC, FUBP1). These tumors account for 5 to 10% of adult gliomas and are of special relevance in the neuro-oncology field because of their frequent chemosensitivity (Louis et al. 2016). The genetics of oligodendrogliomas is relatively well characterized but the mechanisms of oncogenesis for these tumors are poorly understood.
Although oligodendrogliomas prognosis is usually better than that of other adult glioma subtypes, it remains heterogeneous and there is no effective treatment at recurrence after radiotherapy and chemotherapy. Our recent work conducted within the INCa-funded national POLA network has related this clinical heterogeneity to inter-tumoral heterogeneity. Based on a transcriptomic analysis of a large series of oligodendroglial gliomas we identified 3 subgroups, the most aggressive group being characterized by aggressive clinical and molecular pattern. Recent studies, however, have shown a relatively low level of concordance between mRNA and protein expression, emphasizing the need to use proteomic-based approaches to better understand tumor biology. Taking advantage of the POLA cohort, we propose to expand our previous analysis by integrating a proteomic analysis of oligodendrogliomas.
Read more
The aim of this project is to identify drivers of oligodendroglioma subgroups, among which potential druggable targets (i.e receptors, metabolism effectors). For this purpose, the proteomic profiles of 90 oligodendrogliomas will be generated and integrated with transcriptomic, genomic and methylation profiles in order to identify signaling pathways specifically associated with each subtype, especially with the most aggressive one. Associations will be explored between candidate signaling pathways expression and clinical outcomes (survival, progression-free survival, objective response). The relevance of the 2 most promising candidate signaling pathways will be assessed in vitro and in vivo using genetically relevant mouse and xenograft models.
Our project will identify targetable oncogenic pathways associated with poor prognosis that could lead to new therapeutic strategies.
- Conditions
- Oligodendroglioma
- Being tested
- Proteomic analysis
- Keywords
- Oligodendroglioma, proteomic analysis, POLA network
- Medical subject headings
- Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proteomic analysisOther
: Proteomic analysis in the 3 subgroups of oligodendrogliomas (O1, O2 and O3) and in the comparator groups of IDH-mutant astrocytomas, IDH-wildtype glioblastomas and normal brain samples
| Study group | Role | What they receive |
|---|---|---|
| O1 | the more aggressive subgroup of oligodendroglioma samples of 30 patients Receives: Other: Proteomic analysis | |
| O2 | subgroup 2 of oligodendroglioma samples of 30 patients Receives: Other: Proteomic analysis | |
| O3 | subgroup 3 of oligodendroglioma samples of 30 patients Receives: Other: Proteomic analysis | |
| IDH-mutant astrocytomas | patients with IDH-mutant astrocytomas, samples of 15 patients Receives: Other: Proteomic analysis | |
| IDH-wildtype glioblastomas | patients with IDH-wildtype glioblastomas, samples of 15 patients Receives: Other: Proteomic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
proteomic profiles
Concordance of the classification of oligodendrogliomas based on their proteomic profiles with our previously identified oligodendrogliomas subgroups.
Measured: Baseline (at time of diagnosis surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start30 Sep 2020
- Primary completionSep 2021 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OligodendrogliomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843085
- Sponsor's protocol ID
- 69HCL20_0074
- Acronym
- PROGLIO
- Status last verified
- Dec 2020
- First submitted
- 17 Dec 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic Characterization of Aggressive Oligodendrogliomas
- ClinicalTrials.gov ID
- NCT04843085
- Acronym / sponsor ID
- PROGLIO / 69HCL20_0074
- Conditions
- Oligodendroglioma
- Keywords
- Oligodendroglioma, proteomic analysis, POLA network
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 13 Apr 2021 (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.
Oligodendrogliomas represent a distinct subgroup of adult gliomas characterized by specific molecular alterations (1p/19q codeletion, mutations of IDH, TERT promoter, CIC, FUBP1). These tumors account for 5 to 10% of adult gliomas and are of special relevance in the neuro-oncology field because of their frequent chemosensitivity (Louis et al. 2016). The genetics of oligodendrogliomas is relatively well characterized but the mechanisms of oncogenesis for these tumors are poorly understood.
Although oligodendrogliomas prognosis is usually better than that of other adult glioma subtypes, it remains heterogeneous and there is no effective treatment at recurrence after radiotherapy and chemotherapy. Our recent work conducted within the INCa-funded national POLA network has related this clinical heterogeneity to inter-tumoral heterogeneity. Based on a transcriptomic analysis of a large series of oligodendroglial gliomas we identified 3 subgroups, the most aggressive group being characterized by aggressive clinical and molecular pattern. Recent studies, however, have shown a relatively low level of concordance between mRNA and protein expression, emphasizing the need to use proteomic-based approaches to better understand tumor biology. Taking advantage of the POLA cohort, we propose to expand our previous analysis by integrating a proteomic analysis of oligodendrogliomas.
The aim of this project is to identify drivers of oligodendroglioma subgroups, among which potential druggable targets (i.e receptors, metabolism effectors). For this purpose, the proteomic profiles of 90 oligodendrogliomas will be generated and integrated with transcriptomic, genomic and methylation profiles in order to identify signaling pathways specifically associated with each subtype, especially with the most aggressive one. Associations will be explored between candidate signaling pathways expression and clinical outcomes (survival, progression-free survival, objective response). The relevance of the 2 most promising candidate signaling pathways will be assessed in vitro and in vivo using genetically relevant mouse and xenograft models.
Our project will identify targetable oncogenic pathways associated with poor prognosis that could lead to new therapeutic strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| O1 | – | Other: Proteomic analysisthe more aggressive subgroup of oligodendroglioma samples of 30 patients |
| O2 | – | Other: Proteomic analysissubgroup 2 of oligodendroglioma samples of 30 patients |
| O3 | – | Other: Proteomic analysissubgroup 3 of oligodendroglioma samples of 30 patients |
| IDH-mutant astrocytomas | – | Other: Proteomic analysispatients with IDH-mutant astrocytomas, samples of 15 patients |
| IDH-wildtype glioblastomas | – | Other: Proteomic analysispatients with IDH-wildtype glioblastomas, samples of 15 patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- samples of patients with oligodendrolioma, astrocytoma, glioblastoma and normal brain available in the POLA network biobank or the OncoNeuroTek tumor bank (Institut du Cerveau et de la Moelle Épinière)
Key inclusion criteria (4 listed)
- - transcriptomic (microarray) data available or possible to obtain them,
- methylation (450K) data available or possible to obtain them,
- genomic (SNP array) data available or possible to obtain them,
- sufficient material for proteomic analysis (frozen tumor samples)
Key exclusion criteria (1 listed)
- opposed patients
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 |
|---|---|---|
| Proteomic analysis: Proteomic analysis in the 3 subgroups of oligodendrogliomas (O1, O2 and O3) and in the comparator groups of IDH-mutant astrocytomas, IDH-wildtype glioblastomas and normal brain samples | Other | IDH-mutant astrocytomas, IDH-wildtype glioblastomas, O1, O2, O3 |
Primary outcome
proteomic profiles
Time frame: Baseline (at time of diagnosis surgery)
Concordance of the classification of oligodendrogliomas based on their proteomic profiles with our previously identified oligodendrogliomas subgroups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oligodendroglioma, run by Hospices Civils de Lyon at 2 sites in France.
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 4 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 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François DUCRAY, MD (04 72 35 78 06, francois.ducray@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proteomic profiles (time frame: Baseline (at time of diagnosis surgery)). 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 13 Apr 2021.