Clinical trial NCT04516720: Creation of a Clinical Database on Primary Nervous System Tumors
Official title: Creation of a Clinical Database on Primary Nervous System Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nervous System Tumor
Keywords: Primary central nervous system tumors
clinical database
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: all patient with Primary central nervous system tumors and treated at the Montpellier Cancer Institute

Brief 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.

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

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.

Primary outcomes:
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
timeFrame: 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:
measure: 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
timeFrame: 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
measure: To allow the realization of epidemiological studies specific to certain histological subtypes
timeFrame: 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
measure: To facilitate the identification of patients for inclusion in French or European retrospective studies
timeFrame: 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
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Icm Val D'Aurelle
state: Herault
Study officials:
affiliation: Institut régional du Cancer Montpellier
name: Amélie DARLIX, MD
role: STUDY_CHAIR
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