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Clinical Trials/NCT03981016
NCT03981016CompletedNot Applicable

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

Institut du Cancer de Montpellier - Val d'Aurelle24 sites in 1 country105 target enrollmentStarted: March 2, 2015Last updated:
Conditions

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)

Investigators

Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (24)

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