Creation of a Clinical Database on Primary Nervous System Tumors

Nervous System Tumor Clinical Trial

— BDD-NO  

Official title:

Creation of a Clinical Database on Primary Nervous System Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04516720
• Other study ID #: PROICM 2017-01 BNO
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: January 2028

Study information

• Verified date: November 2021
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: Jean-Pierre BLEUSE, MD
• Phone: 04 67 61 31 02
• Email: DRCI-icm105[@]icm.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1700
• Est. completion date: January 2028
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nervous System Neoplasms
• Nervous System Tumor

Intervention

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

Locations

Country	Name	City	State
France	Icm Val D'Aurelle	Montpellier	Herault

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (12)

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. N — View Citation

Boetto J, Bertram L, Moulinié 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 D — View Citation

Capelle 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 Réseau d'Étude des Gliomes. Sponta — View Citation

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 — View Citation

Darlix A, Zouaoui S, Rigau V, Bessaoud F, Figarella-Branger D, Mathieu-Daudé H, Trétarre 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. d — View Citation

DeAngelis LM. Brain tumors. N Engl J Med. 2001 Jan 11;344(2):114-23. Review. — View Citation

Jakola AS, Skjulsvik AJ, Myrmel KS, Sjåvik K, Unsgård 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 — View Citation

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. Epub 2007 Jul 6. Review. Erratum in: Acta Neuropa — View Citation

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 — View Citation

Mandonnet 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, — View Citation

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 — View Citation

Wöhrer A, Waldhör T, Heinzl H, Hackl M, Feichtinger J, Gruber-Mösenbacher U, Kiefer A, Maier H, Motz R, Reiner-Concin A, Richling B, Idriceanu C, Scarpatetti M, Sedivy R, Bankl HC, Stiglbauer W, Preusser M, Rössler K, Hainfellner JA. The Austrian Brain Tu — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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	To allow the realization of epidemiological studies specific to certain histological subtypes	new clinical trials project based on this clinical database	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	To facilitate the identification of patients for inclusion in French or European retrospective studies	new clinical trials project based on this clinical database	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