"In Population" Study of Medical and Surgical Management of Patients With Brain Metastases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 105
- Locations
- 24
- Primary Endpoint
- Number of patients who had a histological study of their brain metastases
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of patients who had a histological study of their brain metastases
Time Frame: 24 months
Number of patients who had a radiotherapy of their brain metastases
Time Frame: 24 months
Number of patients who had a neurosurgery of their brain metastases
Time Frame: 24 months
Number of patients who had a chemotherapy of their brain metastases
Time Frame: 24 months
Secondary Outcomes
- Quality of life by using the quality of life questionnaire core (QLQ-C30).(24 months)
- Overall Survival(Approximately 48 months)
- Quality of life by using the quality of life questionnaire - brain neoplasm (BN20)(24 months)
- Cognitive and neuropsychological functions by using Montreal Cognitive assessment (MoCA)(24 months)