Creation of a Clinical Database on Primary Nervous System Tumors (BDD-NO)

Institut du Cancer de Montpellier - Val d'Aurelle

Status: Enrolling

Conditions: Nervous System Tumor

Treatments: Other: data collection

Study type: Observational

Funder types: Other

Identifiers

NCT04516720

PROICM 2017-01 BNO

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,700 participants in 1 patient group

Primary Nervous System Tumors arm

Description:

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.

Treatment:

Other: data collection