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Central Nervous System TumorCEREMET-LRNCT03981016

Medical and Surgical Management of Patients With Brain Metastases

A study testing Biological collection in people with Central Nervous System Tumor, run by Institut du Cancer de Montpellier - Val d'Aurelle at 12 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Central Nervous System Tumor
What is being tested?
Biological collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
12 sitesFrance
Study dates
2 Mar 2015to 31 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Patient with primary brain tumor
  • Impossibility to be regularly monitored for psychological, family, social, or geographical reasons
  • Subject under guardianship

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • Centre médical Oncodoc Béziers

    Béziers, Hérault, 34000

  • Centre d'Anatomie et Cytologie Pathologiques de Grabels

    Grabels, Hérault, 34000

  • Centre hospitalier régional et universitaire de Montpellier

    Montpellier, Hérault, 34000

  • Clinique Clémentville

    Montpellier, Hérault, 34000

  • Clinique du Millénaire

    Montpellier, Hérault, 34000

  • Institut régional du cancer

    Montpellier, Hérault, 34298

  • Centre hospitalier régional et universitaire de Nîmes

    Nîmes, Gard, 30000

  • Centre médical Oncogard

    Nîmes, Gard, 30000

  • Clinique les Franciscaines

    Nîmes, Gard, 30000

  • Laboratoire d'anatomo-pathologie de Nîmes

    Nîmes, Gard, 30000

  • Centre hospitalier de Perpignan

    Perpignan, Pyrénées-orientales, 66000

  • Clinique Saint-Pierre

    Perpignan, Pyrénées-orientales, 66000

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Biological collection
Keywords
Nervous, Central, Tumor, System
Medical subject headings
Central Nervous System Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological collectionOther

    • 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 groups in NCT03981016
Study groupRoleWhat they receive
Biological collectionExperimentalFor 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
Receives: Other: Biological collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients who had a histological study of their brain metastases

    Measured: 24 months

  2. Number of patients who had a neurosurgery of their brain metastases

    Measured: 24 months

  3. Number of patients who had a radiotherapy of their brain metastases

    Measured: 24 months

  4. Number of patients who had a chemotherapy of their brain metastases

    Measured: 24 months

Secondary outcomes (4)

  1. 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.

    Measured: 24 months

  2. 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.

    Measured: 24 months

  3. Cognitive and neuropsychological functions by using Montreal Cognitive assessment (MoCA)

    Performance on the MoCA (Range : 0-30; higher score indicates better performance)

    Measured: 24 months

  4. Overall Survival

    Measured: Approximately 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2019
  2. Study start2 Mar 2015
  3. Primary completion19 Jan 2018
  4. Study completion31 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03981016
Sponsor's protocol ID
ICM-URC-2014/21
Acronym
CEREMET-LR
Status last verified
Oct 2020
First submitted
6 Jun 2019
Last updated
19 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 22898372

  • 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.

    PubMed 21109143

  • Smedby KE, Brandt L, Backlund 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.

    PubMed 19826419

  • Kocher M, Soffietti R, Abacioglu U, Villa 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.

    PubMed 21041710

Questions about this trial

What is this clinical trial studying?

A study testing Biological collection in people with Central Nervous System Tumor, run by Institut du Cancer de Montpellier - Val d'Aurelle at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients who had a histological study of their brain metastases (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03981016, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.

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