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出境医 / 临床实验 / Medical and Surgical Management of Patients With Brain Metastases (CEREMET-LR)

Medical and Surgical Management of Patients With Brain Metastases (CEREMET-LR)

Study Description
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.

Condition or disease Intervention/treatment Phase
Central Nervous System Tumor Other: Biological collection Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: "In Population" Study of Medical and Surgical Management of Patients With Brain Metastases
Actual Study Start Date : March 2, 2015
Actual Primary Completion Date : January 19, 2018
Actual Study Completion Date : August 31, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Biological collection

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
  • 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
Outcome Measures
Primary Outcome Measures :
  1. Number of patients who had a histological study of their brain metastases [ Time Frame: 24 months ]
  2. Number of patients who had a neurosurgery of their brain metastases [ Time Frame: 24 months ]
  3. Number of patients who had a radiotherapy of their brain metastases [ Time Frame: 24 months ]
  4. Number of patients who had a chemotherapy of their brain metastases [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Quality of life by using the quality of life questionnaire core (QLQ-C30). [ Time Frame: 24 months ]

    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.


  2. Quality of life by using the quality of life questionnaire - brain neoplasm (BN20) [ Time Frame: 24 months ]
    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.

  3. Cognitive and neuropsychological functions by using Montreal Cognitive assessment (MoCA) [ Time Frame: 24 months ]
    Performance on the MoCA (Range : 0-30; higher score indicates better performance)

  4. Overall Survival [ Time Frame: Approximately 48 months ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult ≥ 18 years
  2. Radiological diagnosis of brain metastases
  3. Patient eligible for neurosurgical exeresis or treatment by radio-surgery
  4. Patient treated in a neurosurgery center of the Languedoc-Roussillon region (whatever therapeutic treatment realized on primary tumor)
  5. Present brain metastases not previously treated
  6. Signed informed consent
  7. Patient affiliated to a national insurance system or beneficiary of such a system

Exclusion Criteria:

  1. Patient with primary brain tumor
  2. Impossibility to be regularly monitored for psychological, family, social, or geographical reasons
  3. Subject under guardianship
Contacts and Locations

Locations
Layout table for location information
France
Centre hospitalier régional et universitaire de Nîmes
Nîmes, Gard, France, 30000
Centre médical Oncogard
Nîmes, Gard, France, 30000
Clinique les Franciscaines
Nîmes, Gard, France, 30000
Laboratoire d'anatomo-pathologie de Nîmes
Nîmes, Gard, France, 30000
Centre médical Oncodoc Béziers
Béziers, Hérault, France, 34000
Centre d'Anatomie et Cytologie Pathologiques de Grabels
Grabels, Hérault, France, 34000
Centre hospitalier régional et universitaire de Montpellier
Montpellier, Hérault, France, 34000
Clinique Clémentville
Montpellier, Hérault, France, 34000
Clinique du Millénaire
Montpellier, Hérault, France, 34000
Institut régional du cancer
Montpellier, Hérault, France, 34298
Centre hospitalier de Perpignan
Perpignan, Pyrénées-orientales, France, 66000
Clinique Saint-Pierre
Perpignan, Pyrénées-orientales, France, 66000
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
Layout table for investigator information
Principal Investigator: Luc Bauchet, MD Centre hospitalier de Montpellier
Tracking Information
First Submitted Date  ICMJE June 6, 2019
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE March 2, 2015
Actual Primary Completion Date January 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • Number of patients who had a histological study 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 radiotherapy of their brain metastases [ Time Frame: 24 months ]
  • Number of patients who had a chemotherapy of their brain metastases [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • Quality of life by using the quality of life questionnaire core (QLQ-C30). [ Time Frame: 24 months ]
    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.
  • Quality of life by using the quality of life questionnaire - brain neoplasm (BN20) [ Time Frame: 24 months ]
    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.
  • Cognitive and neuropsychological functions by using Montreal Cognitive assessment (MoCA) [ Time Frame: 24 months ]
    Performance on the MoCA (Range : 0-30; higher score indicates better performance)
  • Overall Survival [ Time Frame: Approximately 48 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Medical and Surgical Management of Patients With Brain Metastases
Official Title  ICMJE "In Population" Study of Medical and Surgical Management of Patients With Brain Metastases
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Central Nervous System Tumor
Intervention  ICMJE Other: Biological collection
  • 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
Study Arms  ICMJE Experimental: Biological collection

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
Intervention: Other: Biological collection
Publications *
  • Davis FG, Dolecek TA, McCarthy BJ, Villano JL. Toward determining the lifetime occurrence of metastatic brain tumors estimated from 2007 United States cancer incidence data. Neuro Oncol. 2012 Sep;14(9):1171-7. doi: 10.1093/neuonc/nos152. Epub 2012 Aug 16.
  • Fox BD, Cheung VJ, Patel AJ, Suki D, Rao G. Epidemiology of metastatic brain tumors. Neurosurg Clin N Am. 2011 Jan;22(1):1-6, v. doi: 10.1016/j.nec.2010.08.007. Review.
  • Smedby KE, Brandt L, Bäcklund ML, Blomqvist P. Brain metastases admissions in Sweden between 1987 and 2006. Br J Cancer. 2009 Dec 1;101(11):1919-24. doi: 10.1038/sj.bjc.6605373. Epub 2009 Oct 13.
  • Kocher M, Soffietti R, Abacioglu U, Villà S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Collette S, Collette L, Mueller RP. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. J Clin Oncol. 2011 Jan 10;29(2):134-41. doi: 10.1200/JCO.2010.30.1655. Epub 2010 Nov 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2019) 		105
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 31, 2020
Actual Primary Completion Date January 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adult ≥ 18 years
  2. Radiological diagnosis of brain metastases
  3. Patient eligible for neurosurgical exeresis or treatment by radio-surgery
  4. Patient treated in a neurosurgery center of the Languedoc-Roussillon region (whatever therapeutic treatment realized on primary tumor)
  5. Present brain metastases not previously treated
  6. Signed informed consent
  7. Patient affiliated to a national insurance system or beneficiary of such a system

Exclusion Criteria:

  1. Patient with primary brain tumor
  2. Impossibility to be regularly monitored for psychological, family, social, or geographical reasons
  3. Subject under guardianship
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03981016
Other Study ID Numbers  ICMJE ICM-URC-2014/21
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut du Cancer de Montpellier - Val d'Aurelle
Study Sponsor  ICMJE Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luc Bauchet, MD Centre hospitalier de Montpellier
PRS Account Institut du Cancer de Montpellier - Val d'Aurelle
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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