Medical and Surgical Management of Patients With Brain Metastases

Study Overview
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Brief Summary
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The integrated cancer research site (SIRIC) of Montpellier proposes to develop a prospective and regional Clinical Database Project and regional biological collection (blood and tumor samples), which is an expanding data collection designed to contribute to a better understand the patient's management with brain metastases including quality of life and neuropsychological/cognitive aspects.

Detailed Description
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Brain metastases (BM) represent the first cause of tumors of the central nervous system. Mortality, morbidity (cognitive disorders, neurological deficits, etc.) and their consequences on the quantity and the quality of life are very high. BM represent a real public health problem. The incidence is increasing related to the ageing of the population and the increase of cancer patient's survival rate. The medico-surgical care has highly evolved (neurosurgical progress, radiosurgery, stereotaxic radiotherapy and new chemo and targeted therapy). Every histological or biological profile requires a specific evaluation, and management. Clinical trials are the reference to establish the efficacy and the toxicity of the new processes, but usually answer only at a single question and for very selected patients. For this reason, the SIRIC Montpellier Cancer proposes to develop a prospective and regional Clinical Database Project and regional biological collection (blood and tumor samples), which is an expanding data collection designed to contribute to a better understand the patient's management with brain metastases including quality of life and neuropsychological/cognitive aspects.

Official Title
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In Population Study of Medical and Surgical Management of Patients With Brain Metastases

Conditions
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Central Nervous System Tumor

Intervention / Treatment
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* Other: Biological collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult ≥ 18 years Radiological diagnosis of brain metastases Patient eligible for neurosurgical exeresis or treatment by radio-surgery Patient treated in a neurosurgery center of the Languedoc-Roussillon region (whatever therapeutic treatment realized on primary tumor) Present brain metastases not previously treated Signed informed consent Patient affiliated to a national insurance system or beneficiary of such a system Exclusion Criteria: Patient with primary brain tumor Impossibility to be regularly monitored for psychological, family, social, or geographical reasons Subject under guardianship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biological collection<br>For the patients include in the study : blood samples collected at different times : Before surgery and during the post-operative visit and frozen tumor samples and / or paraffin samples at the time of surgery and- paraffin around tumor samples at the time of surgery | Other: Biological collection<br>* blood samples collected at different times : Before surgery and during the post-operative visit and frozen tumor samples and / or paraffin samples at the time of surgery and- paraffin around tumor samples at the time of surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who had a histological study of their brain metastases |  | 24 months | 
| Number of patients who had a neurosurgery of their brain metastases |  | 24 months | 
| Number of patients who had a radiotherapy of their brain metastases |  | 24 months | 
| Number of patients who had a chemotherapy of their brain metastases |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life by using the quality of life questionnaire core (QLQ-C30). | The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 (Not at all), 2 (A little), 3 (Quite a bit) and 4 (Very much). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 (very poor) to 7 (excellent). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome. | 24 months | 
| Quality of life by using the quality of life questionnaire - brain neoplasm (BN20) | The QLQ-BN20 questionnaire contains 20 items organized into four scales; future uncertainty (3 items), visual disorder (3 items); motor dysfunction (3 items); and communication deficit (3 items), and seven single items (headaches, seizures, drowsiness, hair loss, itchy skin, weakness of legs, and bladder control). All items are rated on a four-point Likert-type scale ('1=not at all', 2='a little', '3=quite a bit' and '4=very much'), and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms. | 24 months | 
| Cognitive and neuropsychological functions by using Montreal Cognitive assessment (MoCA) | Performance on the MoCA (Range : 0-30; higher score indicates better performance) | 24 months | 
| Overall Survival |  | Approximately 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nervous, Central, Tumor, System