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

November 3, 2021 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

1700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

all patient with Primary central nervous system tumors and treated at the Montpellier Cancer Institute

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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:

  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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Amélie DARLIX, MD, Institut régional du Cancer Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2028

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 14, 2020

First Posted (Actual)

August 18, 2020

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

November 3, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROICM 2017-01 BNO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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