Creation of a Clinical Database on Primary Nervous System Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04516720
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Institut du Cancer de Montpellier - Val d'Aurelle
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Amélie DARLIX, MD
Principal Investigator Affiliation Institut régional du Cancer Montpellier
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Nervous System Tumor
Additional Details

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

Arms & Interventions

Arms

: 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: 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 For the prospective part Inclusion of patients in a coded form in BDD-NO; Collection of clinical data from each patient's medical record.

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Icm Val D'Aurelle, Montpellier, Herault, France

Status

Recruiting

Address

Icm Val D'Aurelle

Montpellier, Herault, 34298

Site Contact

amelie DARLIX, MD

[email protected]

04 67 61 25 57 #+33

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