Nervous System TumorBDD-NONCT04516720
Creation of a Clinical Database on Primary Nervous System Tumors
An observational study of Nervous System Tumor, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
the creation of a clinical database including data for all PCNST patients is of high interest. This database will allow us to develop clinical studies on: The clinical, radiological and biological presentation of tumors, the impact of oncological treatments and the evaluation of survival for the different subtypes of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nervous System Tumor
- What is being tested?
- data collection
- Type of treatment
- Injection or infusion
- How many people
- 1,700 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to Jan 2039
- 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: all patient with Primary central nervous system tumors and treated at the Montpellier Cancer Institute
Who may be able to join
- Adult patient aged ≥ 18, no age limit;
- Diagnosis of Primary central nervous system tumors ;
- Patient treated at the Montpellier Cancer Institute, whatever the treatment received (systemic treatment, radiotherapy or exclusive supportive care);
- For the retrospective part of the study, patient first treated at the Montpellier Cancer Institute between January 1rst, 2004 and the beginning of the prospective part;
- Patient information for the retrospective (patient still alive at the beginning of the study) and prospective study.
Who cannot join
- Secondary lesions of the central nervous system;
- Patient not affiliated to a social protection scheme;
- Subject under tutelage, curatorship or safeguard of justice.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Icm Val D'Aurelle
Montpellier, Herault, 34298
amelie DARLIX, MD, 04 67 61 25 57 ext. +33, amelie.darlix@icm.unicancer.fr
About this study
the creation of a clinical database including data for all PCNST patients is of high interest. This database will allow us to develop clinical studies on:
- The clinical, radiological and biological presentation of tumors, the impact of oncological treatments and the evaluation of survival for the different subtypes of Primary central nervous system tumors (PCNST). This is particularly important for rare histological subtypes of PCNST for which the current knowledge is scarce;
- Clinical, radiological and biological factors predictive of tumor response to treatments;
- Prognostic factors.
Read the detailed description
Primary central nervous system tumors (PCNST) correspond to all primitive tumors involving central nervous system structures, meninges and the origin of the cranial and paraspinal nerves. They have a malignant, benign, or borderline evolution. TPSNC represent a heterogeneous group of tumors, with more than 140 subtypes described in the WHO classification. The causes, prognostic factors, and therapeutic management differ according to the histological subtype.
The incidence of all of TPSNCs ranges from 17.6 to 22.0/105 in North American and European studies. However, because of the high number of different histological subtypes, most of them must be considered as rare tumors. Moreover, they represent a major public health problem due to high morbidity [8] and mortality.
In this context, the creation of a clinical database including data for all PCNST patients is of high interest. This database will allow us to develop clinical studies on:
- The clinical, radiological and biological presentation of tumors, the impact of oncological treatments and the evaluation of survival for the different subtypes of PCNST. This is particularly important for rare histological subtypes of PCNST for which the current knowledge is scarce;
- Clinical, radiological and biological factors predictive of tumor response to treatments;
- Prognostic factors.
The database will also allow us to develop or participate in multicentric clinical studies, at the national or international level, as well as to facilitate the identification of patients for inclusion in translational studies
- Conditions
- Nervous System Tumor
- Being tested
- data collection
- Keywords
- Primary central nervous system tumors, clinical database
- Medical subject headings
- Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
Diagnostic data : date and description of first symptoms,date of radiological diagnosis, tumor localization, number of lesions, date of histological diagnosis, histological diagnostic mode, histological diagnosis, WHO grade (I, II, III or IV), immunohistochemic data, molecular alterations therapeutic sequence : type of treatment, baseline exam before each treatment, surgery, radiothérapy, systemic treatment, clinical study, follow up until death
| Study group | Role | What they receive |
|---|---|---|
| Primary Nervous System Tumors arm | The information letter will be delivered by the investigator physician to the patients to inform them on the study, its implementation and their complete freedom to participate or not.
Clinical Data and Questionnaires:
1. For the retrospective part
* Patient identification based on data from the Medical Information Department (DIM) of the ICM;
* Verification of the eligibility criteria;
* Inclusion of patients in a coded form in BDD-NO;
* Implementation of the database with the data already collected (as an coded EXCEL file) in specific studies (some patients are included in several of these studies): study of diffuse low grade gliomas, study on anaplastic gliomas, study on the place of Bevacizumab in high-grade gliomas, clinical database created
* Collection of clinical data from each patient's medical record
2. For the prospective part
* Inclusion of patients in a coded form in BDD-NO;
* Collection of clinical data from each patient's medical record. Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish an exhaustive database of patients treated for a Primary central nervous system tumors at the Montpellier Cancer Institute, whatever the histological subtype and the oncological treatment
collection of clinical data in the medical record
Measured: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (3)
Realization of clinical studies specific to certain histological subtypes to be carried out on the clinical, radiological and biological presentation of patients, specific oncological treatments and toxicities, prognostic factors and survival data
obtaining reliable clinical data for write new clinical trials project
Measured: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
To allow the realization of epidemiological studies specific to certain histological subtypes
new clinical trials project based on this clinical database
Measured: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
To facilitate the identification of patients for inclusion in French or European retrospective studies
new clinical trials project based on this clinical database
Measured: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start1 Jan 2018
- Primary completionJan 2035 (estimated)
- Study completionJan 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Nervous System TumorStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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
- Other
- Enrolment
- 1,700 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amélie DARLIX, MD, Study chair, Institut régional du Cancer Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516720
- Sponsor's protocol ID
- PROICM 2017-01 BNO
- Acronym
- BDD-NO
- Status last verified
- Feb 2025
- First submitted
- 11 Aug 2020
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Louis DN, Ohgaki H, Wiestler OD, Cavenee WK, Burger PC, Jouvet A, Scheithauer BW, Kleihues P. The 2007 WHO classification of tumours of the central nervous system. Acta Neuropathol. 2007 Aug;114(2):97-109. doi: 10.1007/s00401-007-0243-4. Epub 2007 Jul 6.
PubMed 17618441Louis DN, Perry A, Reifenberger G, von Deimling A, Figarella-Branger D, Cavenee WK, Ohgaki H, Wiestler OD, Kleihues P, Ellison DW. The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary. Acta Neuropathol. 2016 Jun;131(6):803-20. doi: 10.1007/s00401-016-1545-1. Epub 2016 May 9.
PubMed 27157931Ostrom QT, Gittleman H, Fulop J, Liu M, Blanda R, Kromer C, Wolinsky Y, Kruchko C, Barnholtz-Sloan JS. CBTRUS Statistical Report: Primary Brain and Central Nervous System Tumors Diagnosed in the United States in 2008-2012. Neuro Oncol. 2015 Oct;17 Suppl 4(Suppl 4):iv1-iv62. doi: 10.1093/neuonc/nov189. Epub 2015 Oct 27. No abstract available.
PubMed 26511214Wohrer A, Waldhor T, Heinzl H, Hackl M, Feichtinger J, Gruber-Mosenbacher U, Kiefer A, Maier H, Motz R, Reiner-Concin A, Richling B, Idriceanu C, Scarpatetti M, Sedivy R, Bankl HC, Stiglbauer W, Preusser M, Rossler K, Hainfellner JA. The Austrian Brain Tumour Registry: a cooperative way to establish a population-based brain tumour registry. J Neurooncol. 2009 Dec;95(3):401-411. doi: 10.1007/s11060-009-9938-9. Epub 2009 Jun 28.
PubMed 19562257Baldi I, Gruber A, Alioum A, Berteaud E, Lebailly P, Huchet A, Tourdias T, Kantor G, Maire JP, Vital A, Loiseau H; Gironde TSNC Registry Group. Descriptive epidemiology of CNS tumors in France: results from the Gironde Registry for the period 2000-2007. Neuro Oncol. 2011 Dec;13(12):1370-8. doi: 10.1093/neuonc/nor120. Epub 2011 Oct 6.
PubMed 21980160Crocetti E, Trama A, Stiller C, Caldarella A, Soffietti R, Jaal J, Weber DC, Ricardi U, Slowinski J, Brandes A; RARECARE working group. Epidemiology of glial and non-glial brain tumours in Europe. Eur J Cancer. 2012 Jul;48(10):1532-42. doi: 10.1016/j.ejca.2011.12.013. Epub 2012 Jan 7.
PubMed 22227039Darlix A, Zouaoui S, Rigau V, Bessaoud F, Figarella-Branger D, Mathieu-Daude H, Tretarre B, Bauchet F, Duffau H, Taillandier L, Bauchet L. Epidemiology for primary brain tumors: a nationwide population-based study. J Neurooncol. 2017 Feb;131(3):525-546. doi: 10.1007/s11060-016-2318-3. Epub 2016 Nov 16.
PubMed 27853959DeAngelis LM. Brain tumors. N Engl J Med. 2001 Jan 11;344(2):114-23. doi: 10.1056/NEJM200101113440207. No abstract available.
PubMed 11150363Jakola AS, Skjulsvik AJ, Myrmel KS, Sjavik K, Unsgard G, Torp SH, Aaberg K, Berg T, Dai HY, Johnsen K, Kloster R, Solheim O. Surgical resection versus watchful waiting in low-grade gliomas. Ann Oncol. 2017 Aug 1;28(8):1942-1948. doi: 10.1093/annonc/mdx230.
PubMed 28475680Capelle L, Fontaine D, Mandonnet E, Taillandier L, Golmard JL, Bauchet L, Pallud J, Peruzzi P, Baron MH, Kujas M, Guyotat J, Guillevin R, Frenay M, Taillibert S, Colin P, Rigau V, Vandenbos F, Pinelli C, Duffau H; French Reseau d'Etude des Gliomes. Spontaneous and therapeutic prognostic factors in adult hemispheric World Health Organization Grade II gliomas: a series of 1097 cases: clinical article. J Neurosurg. 2013 Jun;118(6):1157-68. doi: 10.3171/2013.1.JNS121. Epub 2013 Mar 15.
PubMed 23495881Boetto J, Bertram L, Moulinie G, Herbet G, Moritz-Gasser S, Duffau H. Low Rate of Intraoperative Seizures During Awake Craniotomy in a Prospective Cohort with 374 Supratentorial Brain Lesions: Electrocorticography Is Not Mandatory. World Neurosurg. 2015 Dec;84(6):1838-44. doi: 10.1016/j.wneu.2015.07.075. Epub 2015 Aug 14.
PubMed 26283485Mandonnet E, Wager M, Almairac F, Baron MH, Blonski M, Freyschlag CF, Barone F, Fontaine D, Pallud J, Hegi M, Viegas C, Zetterling M, Spena G, Goodden J, Rutten GJ, Taillandier L, Foroglu N, Darlix A, Skrap M, Martino J, von Campe G, Madadaki C, Gayat E, de Witt Hamer P, Gil Robles S, Sarubbo S, Santarius T, Bello L, Forster MT, Duffau H. Survey on current practice within the European Low-Grade Glioma Network: where do we stand and what is the next step? Neurooncol Pract. 2017 Dec;4(4):241-247. doi: 10.1093/nop/npw031. Epub 2017 Jan 17.
PubMed 31386020
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Clinical Database on Primary Nervous System Tumors
- ClinicalTrials.gov ID
- NCT04516720
- Acronym / sponsor ID
- BDD-NO / PROICM 2017-01 BNO
- Conditions
- Nervous System Tumor
- Keywords
- Primary central nervous system tumors, clinical database
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Jan 2035 (estimated)
- Study completion
- Jan 2039 (estimated)
- First posted
- 18 Aug 2020 (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.
the creation of a clinical database including data for all PCNST patients is of high interest. This database will allow us to develop clinical studies on:
- The clinical, radiological and biological presentation of tumors, the impact of oncological treatments and the evaluation of survival for the different subtypes of Primary central nervous system tumors (PCNST). This is particularly important for rare histological subtypes of PCNST for which the current knowledge is scarce;
- Clinical, radiological and biological factors predictive of tumor response to treatments;
- Prognostic factors.
Detailed description
Primary central nervous system tumors (PCNST) correspond to all primitive tumors involving central nervous system structures, meninges and the origin of the cranial and paraspinal nerves. They have a malignant, benign, or borderline evolution. TPSNC represent a heterogeneous group of tumors, with more than 140 subtypes described in the WHO classification. The causes, prognostic factors, and therapeutic management differ according to the histological subtype.
The incidence of all of TPSNCs ranges from 17.6 to 22.0/105 in North American and European studies. However, because of the high number of different histological subtypes, most of them must be considered as rare tumors. Moreover, they represent a major public health problem due to high morbidity [8] and mortality.
In this context, the creation of a clinical database including data for all PCNST patients is of high interest. This database will allow us to develop clinical studies on:
- The clinical, radiological and biological presentation of tumors, the impact of oncological treatments and the evaluation of survival for the different subtypes of PCNST. This is particularly important for rare histological subtypes of PCNST for which the current knowledge is scarce;
- Clinical, radiological and biological factors predictive of tumor response to treatments;
- Prognostic factors.
The database will also allow us to develop or participate in multicentric clinical studies, at the national or international level, as well as to facilitate the identification of patients for inclusion in translational studies
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Nervous System Tumors arm | – | Other: data collectionThe information letter will be delivered by the investigator physician to the patients to inform them on the study, its implementation and their complete freedom to participate or not. Clinical Data and Questionnaires: 1. For the retrospective part * Patient identification based on data from the Medical Information Department (DIM) of the ICM; * Verification of the eligibility criteria; * Inclusion of patients in a coded form in BDD-NO; * Implementation of the database with the data already collected (as an coded EXCEL file) in specific studies (some patients are included in several of these studies): study of diffuse low grade gliomas, study on anaplastic gliomas, study on the place of Bevacizumab in high-grade gliomas, clinical database created * Collection of clinical data from each patient's medical record 2. For the prospective part * Inclusion of patients in a coded form in BDD-NO; * Collection of clinical data from each patient's medical record. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patient with Primary central nervous system tumors and treated at the Montpellier Cancer Institute
Key inclusion criteria (5 listed)
- Adult patient aged ≥ 18, no age limit;
- Diagnosis of Primary central nervous system tumors ;
- Patient treated at the Montpellier Cancer Institute, whatever the treatment received (systemic treatment, radiotherapy or exclusive supportive care);
- For the retrospective part of the study, patient first treated at the Montpellier Cancer Institute between January 1rst, 2004 and the beginning of the prospective part;
- Patient information for the retrospective (patient still alive at the beginning of the study) and prospective study.
Key exclusion criteria (3 listed)
- Secondary lesions of the central nervous system;
- Patient not affiliated to a social protection scheme;
- Subject under tutelage, curatorship or safeguard of justice.
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 |
|---|---|---|
| data collectionDiagnostic data : date and description of first symptoms,date of radiological diagnosis, tumor localization, number of lesions, date of histological diagnosis, histological diagnostic mode, histological diagnosis, WHO grade (I, II, III or IV), immunohistochemic data, molecular alterations therapeutic sequence : type of treatment, baseline exam before each treatment, surgery, radiothérapy, systemic treatment, clinical study, follow up until death | Other | Primary Nervous System Tumors arm |
Primary outcome
Establish an exhaustive database of patients treated for a Primary central nervous system tumors at the Montpellier Cancer Institute, whatever the histological subtype and the oncological treatment
Time frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
collection of clinical data in the medical record
3 secondary outcomes
Realization of clinical studies specific to certain histological subtypes to be carried out on the clinical, radiological and biological presentation of patients, specific oncological treatments and toxicities, prognostic factors and survival data
Time frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
To allow the realization of epidemiological studies specific to certain histological subtypes
Time frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
To facilitate the identification of patients for inclusion in French or European retrospective studies
Time frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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 12 Feb 2025.
- Results publication: PubMed 17618441Louis DN, Ohgaki H, Wiestler OD, Cavenee WK, Burger PC, Jouvet A, Scheithauer BW, Kleihues P. The 2007 WHO classification of tumours of the central nervous system. Acta Neuropathol. 2007 Aug;114(2):97-109. doi: 10.1007/s00401-007-0243-4. Epub 2007 Jul 6.
- Results publication: PubMed 27157931Louis DN, Perry A, Reifenberger G, von Deimling A, Figarella-Branger D, Cavenee WK, Ohgaki H, Wiestler OD, Kleihues P, Ellison DW. The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary. Acta Neuropathol. 2016 Jun;131(6):803-20. doi: 10.1007/s00401-016-1545-1. Epub 2016 May 9.
- Results publication: PubMed 26511214Ostrom QT, Gittleman H, Fulop J, Liu M, Blanda R, Kromer C, Wolinsky Y, Kruchko C, Barnholtz-Sloan JS. CBTRUS Statistical Report: Primary Brain and Central Nervous System Tumors Diagnosed in the United States in 2008-2012. Neuro Oncol. 2015 Oct;17 Suppl 4(Suppl 4):iv1-iv62. doi: 10.1093/neuonc/nov189. Epub 2015 Oct 27. No abstract available.
- Results publication: PubMed 19562257Wohrer A, Waldhor T, Heinzl H, Hackl M, Feichtinger J, Gruber-Mosenbacher U, Kiefer A, Maier H, Motz R, Reiner-Concin A, Richling B, Idriceanu C, Scarpatetti M, Sedivy R, Bankl HC, Stiglbauer W, Preusser M, Rossler K, Hainfellner JA. The Austrian Brain Tumour Registry: a cooperative way to establish a population-based brain tumour registry. J Neurooncol. 2009 Dec;95(3):401-411. doi: 10.1007/s11060-009-9938-9. Epub 2009 Jun 28.
- Results publication: PubMed 21980160Baldi I, Gruber A, Alioum A, Berteaud E, Lebailly P, Huchet A, Tourdias T, Kantor G, Maire JP, Vital A, Loiseau H; Gironde TSNC Registry Group. Descriptive epidemiology of CNS tumors in France: results from the Gironde Registry for the period 2000-2007. Neuro Oncol. 2011 Dec;13(12):1370-8. doi: 10.1093/neuonc/nor120. Epub 2011 Oct 6.
- Results publication: PubMed 22227039Crocetti E, Trama A, Stiller C, Caldarella A, Soffietti R, Jaal J, Weber DC, Ricardi U, Slowinski J, Brandes A; RARECARE working group. Epidemiology of glial and non-glial brain tumours in Europe. Eur J Cancer. 2012 Jul;48(10):1532-42. doi: 10.1016/j.ejca.2011.12.013. Epub 2012 Jan 7.
- Results publication: PubMed 27853959Darlix A, Zouaoui S, Rigau V, Bessaoud F, Figarella-Branger D, Mathieu-Daude H, Tretarre B, Bauchet F, Duffau H, Taillandier L, Bauchet L. Epidemiology for primary brain tumors: a nationwide population-based study. J Neurooncol. 2017 Feb;131(3):525-546. doi: 10.1007/s11060-016-2318-3. Epub 2016 Nov 16.
- Results publication: PubMed 11150363DeAngelis LM. Brain tumors. N Engl J Med. 2001 Jan 11;344(2):114-23. doi: 10.1056/NEJM200101113440207. No abstract available.
- Results publication: PubMed 28475680Jakola AS, Skjulsvik AJ, Myrmel KS, Sjavik K, Unsgard G, Torp SH, Aaberg K, Berg T, Dai HY, Johnsen K, Kloster R, Solheim O. Surgical resection versus watchful waiting in low-grade gliomas. Ann Oncol. 2017 Aug 1;28(8):1942-1948. doi: 10.1093/annonc/mdx230.
- Results publication: PubMed 23495881Capelle L, Fontaine D, Mandonnet E, Taillandier L, Golmard JL, Bauchet L, Pallud J, Peruzzi P, Baron MH, Kujas M, Guyotat J, Guillevin R, Frenay M, Taillibert S, Colin P, Rigau V, Vandenbos F, Pinelli C, Duffau H; French Reseau d'Etude des Gliomes. Spontaneous and therapeutic prognostic factors in adult hemispheric World Health Organization Grade II gliomas: a series of 1097 cases: clinical article. J Neurosurg. 2013 Jun;118(6):1157-68. doi: 10.3171/2013.1.JNS121. Epub 2013 Mar 15.
- Results publication: PubMed 26283485Boetto J, Bertram L, Moulinie G, Herbet G, Moritz-Gasser S, Duffau H. Low Rate of Intraoperative Seizures During Awake Craniotomy in a Prospective Cohort with 374 Supratentorial Brain Lesions: Electrocorticography Is Not Mandatory. World Neurosurg. 2015 Dec;84(6):1838-44. doi: 10.1016/j.wneu.2015.07.075. Epub 2015 Aug 14.
- Results publication: PubMed 31386020Mandonnet E, Wager M, Almairac F, Baron MH, Blonski M, Freyschlag CF, Barone F, Fontaine D, Pallud J, Hegi M, Viegas C, Zetterling M, Spena G, Goodden J, Rutten GJ, Taillandier L, Foroglu N, Darlix A, Skrap M, Martino J, von Campe G, Madadaki C, Gayat E, de Witt Hamer P, Gil Robles S, Sarubbo S, Santarius T, Bello L, Forster MT, Duffau H. Survey on current practice within the European Low-Grade Glioma Network: where do we stand and what is the next step? Neurooncol Pract. 2017 Dec;4(4):241-247. doi: 10.1093/nop/npw031. Epub 2017 Jan 17.
- 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.
Amélie DARLIX, MD study chair
Institut régional du Cancer Montpellier
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 Nervous System Tumor, run by Institut du Cancer de Montpellier - Val d'Aurelle 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?
The sponsor lists 5 inclusion and 3 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 12 Feb 2025. 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?
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 Aurore MOUSSION, MD (04 67 61 31 02 ext. +33, DRCI-icm105@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish an exhaustive database of patients treated for a Primary central nervous system tumors at the Montpellier Cancer Institute, whatever the histological subtype and the oncological treatment (time frame: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months). 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 NCT04516720, which also lists 12 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 12 Feb 2025.