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NCT Number: NCT04516720

Creation of a Clinical Database on Primary Nervous System Tumors

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Icm Val D'Aurelle

Montpellier, Herault, 34298, France

Location status: Recruiting

Location contact

amelie DARLIX, MD

CONTACT

[email protected]

04 67 61 25 57 ext. +33

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

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 outcomes

  1. 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

    collection of clinical data in the medical record

Secondary outcomes

  1. 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

    obtaining reliable clinical data for write new clinical trials project

  2. 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

    new clinical trials project based on this clinical database

  3. 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

    new clinical trials project based on this clinical database

Study contacts

Contact information is provided by the study sponsor or research team.

Aurore MOUSSION, MD

CONTACT

[email protected]

04 67 61 31 02 ext. +33

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Acronym: BDD-NO

Important dates

Study start
2018
Primary completion
2035
Study completion
2039
First posted
Aug 18, 2020
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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