Brain TumorONCONEUROTEK 2NCT06314607
Genetic and Molecular Characterization of Nervous System Lesions
An observational study of Brain Tumor and Brain Lesion (General), run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Primary and secondary brain tumors, the leading cause of death from cancer before the age of 35, represent a complex and heterogeneous group of pathologies with a generally poor prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Brain Lesion (General)
- What is being tested?
- Prospective Biological Collection and Retrospective Biological Collection
- How many people
- 10,000 participants
- Where
- 3 sitesFrance
- Study dates
- 26 Mar 2024to Mar 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients with brain lesions, including pregnant women (e.g. tumors: patient with glioma, but also with primary brain lymphoma, meningioma, or primary brain tumor of a rare subtype, secondary tumor).
Who may be able to join
- Any patient operated on for a brain lesion (e.g. tumors: glioma, LCPSNC, meningioma, or rare tumor) and/or followed up for one of these pathologies.
- Age ≥ 18 years
- Consent or non-opposition of the patient or his/her legal representative (guardian) to participate in the study.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Service de Neurochirurgie - Hôpital de la Pitié Salpêtrière
Paris, 75013
Bertand Mathon, Dr, 01 84 82 73 63 ext. +33, bertrand.mathon@aphp.fr
- Recruiting
Service de Neurologie 2 -Hôpital de la Pitié Salpêtrière
Paris, 75013
Marc Sanson, Prof, 01 42 16 03 91 ext. +33, marc.sanson@aphp.fr
- Recruiting
Service de Radiothérapie - Hôpital de la Pittié Salpêtrière
Paris, 75013
Julian Jacob, Dr, 01 84 82 74 90 ext. +33, julian.jacob@aphp.fr
About this study
Primary and secondary brain tumors, the leading cause of death from cancer before the age of 35, represent a complex and heterogeneous group of pathologies with a generally poor prognosis. Knowledge of these tumors has made enormous strides thanks to access to biological samples, leading to a much more robust, reliable and precise histo-pronostic classification, but also, increasingly, to the identification of theranostic targets.
Despite these advances, there is a real need to refine diagnostic and prognostic classification, identify the biological mechanisms involved in the formation and progression of these pathologies, develop new targeted strategies, and devise minimally invasive follow-up methods (liquid biopsies).
Read more
In addition, certain non-tumoral brain lesions (e.g. malformations) can be similarly classified according to their molecular and mutational profile.
This project aims to make a decisive contribution to these objectives.
Read the detailed description
Over the past 15 years, knowledge of these tumors has increased exponentially, thanks to the genomic revolution (high-throughput sequencing, methylome analysis), which has improved their classification, defining homogeneous prognostic, predictive and even theranostic groups (BRAF, FGFR, NTRK). This knowledge has only progressed thanks to access to tumor samples, but also to constitutional DNA and liquid biopsies.
The histo-pronostic classification of these tumors is constantly evolving, as evidenced by the new WHO 2021 version, which integrates more and more molecular markers for diagnosis (in which the team participated), and considerably modifies nosological frameworks. This process began with the 2007 classification, which was purely morphological and particularly unsatisfactory, with over 30% inter-observer diagnostic discordance, and the 2016 version has considerably clarified the classification of grade 2 and 3 gliomas, by integrating biomarkers that are now unavoidable, such as 1p19q codeletion and IDH1 and IDH2 mutation: however, it has taken several years for these markers to be routinely performed and managed. The extremely rapid evolution of diagnostic criteria is illustrated by the c-impact now initiative, which has regularly revisited the classification of primary brain tumours, and gliomas in particular, in the light of the most recent publications, and on which the 2021 classification is based: however, certain data are still fragile and criticized because they are based on limited series (for example, the definition of grade 2 gliomas, reclassified as "molecular glioblastomas".
Glioblastoma and other diffuse gliomas are incurable, lethal diseases that are resistant to conventional treatments (radiotherapy, chemotherapy). Compared with other cancers, the number of effective treatments and therefore treatment lines available is limited. The longitudinal study of these diseases is essential to understanding the mechanisms of resistance to treatment and identifying new vulnerabilities. Our team actively contributes to this research, for which tumor samples at initial diagnosis, but also at recurrence and possibly post-mortem are invaluable.
Given its strengths, our team can now make a decisive contribution to improving diagnosis and prediction in the management of primary brain tumors.
First and foremost, the team represents Europe's leading center for the management of glioma patients. Between 10% and 15% of patients with primary brain tumors in France are treated in Neuro-oncology at La Salpêtrière.
Beyond the diagnostic aspect, high-throughput sequencing techniques have made it possible to identify anomalies that can be used in oncology. However, these are still rarely detected in gliomas. Only a very limited number of markers, included in the WHO2016 classification, which we helped to identify, are now part of the "standard" management of these patients. The rest are part of research. However, we have recently shown that a broader search for actionable abnormalities carried out in specific studies, has enabled patients to benefit from personalized therapies with a real gain in survival, but access is still restricted via the Seqoia program, to a small number of patients.
In conclusion, there is a real need to refine diagnostic and prognostic classification, identify new targeted strategies, and develop minimally invasive follow-up methods (liquid biopsies).
Some lesions, however, are not tumoral in nature, but rather malformative, such as cerebral dysplasia or vascular malformations. Interestingly, somatic mutations are also found at the origin of these lesions, making it possible to classify them, and above all to propose treatments targeting these alterations. As these non-tumoral lesions are subject to a diagnostic and sometimes therapeutic strategy similar to tumors, and as our team has developed real expertise in this field, and above all as it is not always possible to distinguish, pre-operatively, between a malformative lesion and a tumor, we have broadened the search, and retain the term "lesion" in the patient information and consent form.
- Conditions
- Brain Tumor, Brain Lesion (General)
- Being tested
- Prospective Biological Collection, Retrospective Biological Collection
- Keywords
- Brain tumor, Cerebral Lesions
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective Biological CollectionGenetic
All samples that can be collected at each visit :
- Saliva sampling (added by the research)
- Collection of 2 to 4 additional tubes of blood (maximum 56mL) (added by the research if blood sampling in routine care)
- Urine and stool samples (added by the research)
- CSF sample residues (added by the research if lumbar punction in routine care)
- Lesion sample residues and surgical waste fragments (added by the research if surgery in routine care)
Retrospective Biological CollectionGenetic
Requalification of all biological samples obtained as part of ONCONEUROTEK research, with patient consent (blood, saliva, urine, Stool, CSF, lesion sample and surgical waste fragments)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients already included in the first ONCONEUROTEK (retrospective) study and followed up in the participating center : at their next hospitalization or consultation at Pitié Salpêtrière, they will be given an information note and a consent form (NIFC) informing them of the ONCONEUROTEK 2 study.
(This population concerns all patients in the relevant departments with a last news date < 2 years) Receives: Genetic: Prospective Biological Collection; Genetic: Retrospective Biological Collection | |
| Group 2 | Patients included prospectively : Patients who may be included in this study will be informed of its objectives and procedures by the doctor in charge of their follow-up, during a consultation visit or routine hospitalization, by means of an information note.
(This population concerns around 1,000 patients per year, i.e. around 10,000 patients over 10 years) Receives: Genetic: Prospective Biological Collection; Genetic: Retrospective Biological Collection | |
| Group 3 | This group concerns patients already included in the ONCONEUROTEK study (retrospective) but not currently being followed at the Pitié Salpêtrière hospital. Specifically, patients who are known to the investigators to still be alive. In this case, an information note and a non-opposition form (NINO) will be sent to them by mail to :
* inform them of the regulatory update under the Loi Jardé and the RGPD
* and collect their non-opposition to the re-use of their data and samples.
* If no reply is received within one month, the patient will be deemed not to have objected to the re-use of his or her data and samples in the ONCONEUROTEK 2 study.
(This population concerns all patients in the relevant departments with a last news date > 2 years) Receives: Genetic: Retrospective Biological Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the clinical markers with the evolution of brain lesions.
Study of patients' disease-related data in their medical records
Measured: 10 years
Study the biological markers with the evolution of brain lesions.
Study blood, saliva, urine, stool and CSF samples
Measured: 10 years
Study the anatomopathological markers with the evolution of brain lesions.
Study of cerebral lesion tissues
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start26 Mar 2024
- Primary completionMar 2034 (estimated)
- Study completionMar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314607
- Sponsor's protocol ID
- APHP220498
- Acronym
- ONCONEUROTEK 2
- Status last verified
- Aug 2024
- First submitted
- 11 Mar 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Molecular Characterization of Nervous System Lesions
- ClinicalTrials.gov ID
- NCT06314607
- Acronym / sponsor ID
- ONCONEUROTEK 2 / APHP220498
- Conditions
- Brain Tumor, Brain Lesion (General)
- Keywords
- Brain tumor, Cerebral Lesions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- Mar 2034 (estimated)
- Study completion
- Mar 2034 (estimated)
- First posted
- 18 Mar 2024 (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.
Primary and secondary brain tumors, the leading cause of death from cancer before the age of 35, represent a complex and heterogeneous group of pathologies with a generally poor prognosis. Knowledge of these tumors has made enormous strides thanks to access to biological samples, leading to a much more robust, reliable and precise histo-pronostic classification, but also, increasingly, to the identification of theranostic targets.
Despite these advances, there is a real need to refine diagnostic and prognostic classification, identify the biological mechanisms involved in the formation and progression of these pathologies, develop new targeted strategies, and devise minimally invasive follow-up methods (liquid biopsies).
In addition, certain non-tumoral brain lesions (e.g. malformations) can be similarly classified according to their molecular and mutational profile.
This project aims to make a decisive contribution to these objectives.
Detailed description
Over the past 15 years, knowledge of these tumors has increased exponentially, thanks to the genomic revolution (high-throughput sequencing, methylome analysis), which has improved their classification, defining homogeneous prognostic, predictive and even theranostic groups (BRAF, FGFR, NTRK). This knowledge has only progressed thanks to access to tumor samples, but also to constitutional DNA and liquid biopsies.
The histo-pronostic classification of these tumors is constantly evolving, as evidenced by the new WHO 2021 version, which integrates more and more molecular markers for diagnosis (in which the team participated), and considerably modifies nosological frameworks. This process began with the 2007 classification, which was purely morphological and particularly unsatisfactory, with over 30% inter-observer diagnostic discordance, and the 2016 version has considerably clarified the classification of grade 2 and 3 gliomas, by integrating biomarkers that are now unavoidable, such as 1p19q codeletion and IDH1 and IDH2 mutation: however, it has taken several years for these markers to be routinely performed and managed. The extremely rapid evolution of diagnostic criteria is illustrated by the c-impact now initiative, which has regularly revisited the classification of primary brain tumours, and gliomas in particular, in the light of the most recent publications, and on which the 2021 classification is based: however, certain data are still fragile and criticized because they are based on limited series (for example, the definition of grade 2 gliomas, reclassified as "molecular glioblastomas".
Glioblastoma and other diffuse gliomas are incurable, lethal diseases that are resistant to conventional treatments (radiotherapy, chemotherapy). Compared with other cancers, the number of effective treatments and therefore treatment lines available is limited. The longitudinal study of these diseases is essential to understanding the mechanisms of resistance to treatment and identifying new vulnerabilities. Our team actively contributes to this research, for which tumor samples at initial diagnosis, but also at recurrence and possibly post-mortem are invaluable.
Given its strengths, our team can now make a decisive contribution to improving diagnosis and prediction in the management of primary brain tumors.
First and foremost, the team represents Europe's leading center for the management of glioma patients. Between 10% and 15% of patients with primary brain tumors in France are treated in Neuro-oncology at La Salpêtrière.
Beyond the diagnostic aspect, high-throughput sequencing techniques have made it possible to identify anomalies that can be used in oncology. However, these are still rarely detected in gliomas. Only a very limited number of markers, included in the WHO2016 classification, which we helped to identify, are now part of the "standard" management of these patients. The rest are part of research. However, we have recently shown that a broader search for actionable abnormalities carried out in specific studies, has enabled patients to benefit from personalized therapies with a real gain in survival, but access is still restricted via the Seqoia program, to a small number of patients.
In conclusion, there is a real need to refine diagnostic and prognostic classification, identify new targeted strategies, and develop minimally invasive follow-up methods (liquid biopsies).
Some lesions, however, are not tumoral in nature, but rather malformative, such as cerebral dysplasia or vascular malformations. Interestingly, somatic mutations are also found at the origin of these lesions, making it possible to classify them, and above all to propose treatments targeting these alterations. As these non-tumoral lesions are subject to a diagnostic and sometimes therapeutic strategy similar to tumors, and as our team has developed real expertise in this field, and above all as it is not always possible to distinguish, pre-operatively, between a malformative lesion and a tumor, we have broadened the search, and retain the term "lesion" in the patient information and consent form.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Genetic: Prospective Biological Collection, Genetic: Retrospective Biological CollectionPatients already included in the first ONCONEUROTEK (retrospective) study and followed up in the participating center : at their next hospitalization or consultation at Pitié Salpêtrière, they will be given an information note and a consent form (NIFC) informing them of the ONCONEUROTEK 2 study. (This population concerns all patients in the relevant departments with a last news date < 2 years) |
| Group 2 | – | Genetic: Prospective Biological Collection, Genetic: Retrospective Biological CollectionPatients included prospectively : Patients who may be included in this study will be informed of its objectives and procedures by the doctor in charge of their follow-up, during a consultation visit or routine hospitalization, by means of an information note. (This population concerns around 1,000 patients per year, i.e. around 10,000 patients over 10 years) |
| Group 3 | – | Genetic: Retrospective Biological CollectionThis group concerns patients already included in the ONCONEUROTEK study (retrospective) but not currently being followed at the Pitié Salpêtrière hospital. Specifically, patients who are known to the investigators to still be alive. In this case, an information note and a non-opposition form (NINO) will be sent to them by mail to : * inform them of the regulatory update under the Loi Jardé and the RGPD * and collect their non-opposition to the re-use of their data and samples. * If no reply is received within one month, the patient will be deemed not to have objected to the re-use of his or her data and samples in the ONCONEUROTEK 2 study. (This population concerns all patients in the relevant departments with a last news date > 2 years) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with brain lesions, including pregnant women (e.g. tumors: patient with glioma, but also with primary brain lymphoma, meningioma, or primary brain tumor of a rare subtype, secondary tumor).
Key inclusion criteria (3 listed)
- Any patient operated on for a brain lesion (e.g. tumors: glioma, LCPSNC, meningioma, or rare tumor) and/or followed up for one of these pathologies.
- Age ≥ 18 years
- Consent or non-opposition of the patient or his/her legal representative (guardian) to participate in the study.
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 |
|---|---|---|
| Prospective Biological CollectionAll samples that can be collected at each visit : * Saliva sampling (added by the research) * Collection of 2 to 4 additional tubes of blood (maximum 56mL) (added by the research if blood sampling in routine care) * Urine and stool samples (added by the research) * CSF sample residues (added by the research if lumbar punction in routine care) * Lesion sample residues and surgical waste fragments (added by the research if surgery in routine care) | Genetic | Group 1, Group 2 |
| Retrospective Biological CollectionRequalification of all biological samples obtained as part of ONCONEUROTEK research, with patient consent (blood, saliva, urine, Stool, CSF, lesion sample and surgical waste fragments) | Genetic | Group 1, Group 2, Group 3 |
Primary outcome
Study the clinical markers with the evolution of brain lesions.
Time frame: 10 years
Study of patients' disease-related data in their medical records
Study the biological markers with the evolution of brain lesions.
Time frame: 10 years
Study blood, saliva, urine, stool and CSF samples
Study the anatomopathological markers with the evolution of brain lesions.
Time frame: 10 years
Study of cerebral lesion tissues
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Brain Lesion (General), run by Assistance Publique - Hôpitaux de Paris at 3 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 3 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: looking for participants now, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Sanson, Prof (01 42 16 03 91 ext. +33, marc.sanson@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the clinical markers with the evolution of brain lesions. (time frame: 10 years). The study lists 3 primary outcomes in all. 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 4 Sep 2024.