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

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle (Other)

Overall Status

Completed

CT.gov ID

NCT03981016

Collaborator

(none)

105

Enrollment

Locations

Arm

Actual Duration (Months)

8.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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	N/A

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

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 :

Mar 2, 2015

Actual Primary Completion Date :

Jan 19, 2018

Actual Study Completion Date :

Aug 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

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

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

Quality of life by using the quality of life questionnaire core (QLQ-C30). [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) [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) [24 months]
Performance on the MoCA (Range : 0-30; higher score indicates better performance)
Overall Survival [Approximately 48 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre hospitalier régional et universitaire de Nîmes	Nîmes	Gard	France	30000
2	Centre médical Oncogard	Nîmes	Gard	France	30000
3	Clinique les Franciscaines	Nîmes	Gard	France	30000
4	Laboratoire d'anatomo-pathologie de Nîmes	Nîmes	Gard	France	30000
5	Centre médical Oncodoc Béziers	Béziers	Hérault	France	34000
6	Centre d'Anatomie et Cytologie Pathologiques de Grabels	Grabels	Hérault	France	34000
7	Centre hospitalier régional et universitaire de Montpellier	Montpellier	Hérault	France	34000
8	Clinique Clémentville	Montpellier	Hérault	France	34000
9	Clinique du Millénaire	Montpellier	Hérault	France	34000
10	Institut régional du cancer	Montpellier	Hérault	France	34298
11	Centre hospitalier de Perpignan	Perpignan	Pyrénées-orientales	France	66000
12	Clinique Saint-Pierre	Perpignan	Pyrénées-orientales	France	66000