Creation of a Clinical Database on Primary Nervous System Tumors

Overview

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

Interventions

• Other data collection
  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

Primary outcome measures

• 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]

Secondary outcome measures (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 [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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• Secondary lesions of the central nervous system;
• Patient not affiliated to a social protection scheme;
• Subject under tutelage, curatorship or safeguard of justice.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 1 center

• Icm Val D'Aurelle — Montpellier

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. PMID 17618441
• Louis 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. PMID 27157931
• Ostrom 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. PMID 26511214
• Wohrer 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 PMID 19562257
• Baldi 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. PMID 21980160
• Crocetti 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. PMID 22227039
• Darlix 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. PMID 27853959
• DeAngelis LM. Brain tumors. N Engl J Med. 2001 Jan 11;344(2):114-23. doi: 10.1056/NEJM200101113440207. No abstract available. PMID 11150363

Identifiers

NCT: NCT04516720 · PROICM 2017-01 BNO

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗