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Study of Neurological Complication After Radiotherapy for High Grade Glioblastoma (EPIBRAINRAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02544178
Recruitment Status : Unknown
Verified September 2016 by Sophie JACOB, Institut de Radioprotection et de Surete Nucleaire.
Recruitment status was:  Recruiting
First Posted : September 9, 2015
Last Update Posted : September 22, 2016
Sponsor:
Collaborator:
Centre National de la Recherche Scientifique, France
Information provided by (Responsible Party):
Sophie JACOB, Institut de Radioprotection et de Surete Nucleaire

Brief Summary:

The survival time and the number of long time survivors after radiotherapy in brain cancer patients have increased for the last decades. Therefore the topic of late-delayed neurotoxic effects of this therapy gains more and more importance. Among these side effects, the main and most frequent one is the leukoencephalopathy, a diffused and progressive damage of the white matter characterized by myelin loss, loss of axons and vascular lesions. The incidence rate assessment, as well as the occurrence time, is based on retrospective studies with low numbers of patients, but seems to reach 30 to 50 % of the patients according to the follow-up. The risk seems to be increased during the first two years after the radiotherapy, but persists for decades.

To gain further insight in the radiation-induced leukoencephalopathy, the objective of this project is to study the onset and evolution of leukoencephalopathy in a 3-year prospective cohort of patients having undergone cerebral radiotherapy for glioma (stage 3-4), using specific cognitive tests, Magnetic Resonance Imagery (MRI) scans of the brain and predictive bio-markers of cognitive impairments.


Condition or disease Intervention/treatment
Leukoencephalopathy Radiation: brain radiotherapy

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: EPIBRAINRAD : Study of Neurological Complication After Radiotherapy for Glioblastoma High Grade
Study Start Date : April 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
diagnostic procedure
neurocognitive tests before and after radiotherapy
Radiation: brain radiotherapy
effect of cerebral radiotherapy on neurocognitive state




Primary Outcome Measures :
  1. decrease of 1.5 SD of Compurerized Speed Cognitive test [ Time Frame: before radiotherapy, at 12 and 36 months ]

Secondary Outcome Measures :
  1. sensitivity and specificity of the Compurerized Speed Cognitive test [ Time Frame: at the inclusion time (before radiotherapy), at 12 and 36 months ]
    comparison of the CSCT result with the results of the complete neurocognitive evaluation.

  2. dosimetric prognostic factors of neurocognitive defects [ Time Frame: at the inclusion time (before radiotherapy), and at 12 and 36 months ]
    collection of histograms of dose-volumes of specific organs and areas based on data from radiotherapy treatment plan.

  3. levels of biomarkers before and after radiotherapy [ Time Frame: at the inclusion time (before radiotherapy), , at 12 and 36 months ]
    levels of homocysteine, protein S100B,specific isoprostanes (8,12-iso-iPF2α-VI),micro RNA, microparticules

  4. radiological prognostic factors of neurocognitive defects [ Time Frame: at the inclusion time (before radiotherapy), and at 12 and 36 months ]
    white matter abnormalities and cortical atrophy.The white matter lesion quantification will follow the procedure described by Wahlund et al (Wahlund 2001) using a 4 points scale (0: no lesion; 1: focal lesions; 2: beginning confluence of lesion; 3: diffuse involvement of the entire region). The cortical atrophy quantification will follow the procedure described by Pasquier et al (Pasquier 1996) using a 4 point scale (0: absence of atrophy; 1: mild atrophy; 2: moderate atrophy; 3: severe atrophy).


Biospecimen Retention:   Samples Without DNA
  • protéin S-100B, 8,12-iso-iPF2α-VI level, homocystéine
  • micro RNAs (brain-miR-112, brain-miR-161, hsa-let-7d-3p, hsa-miR-5010-3p, hsa-miR-26a-5p, hsamiR-1285-5p, hsa-miR-151a-3p, hsamiR-103a-3p, hsa-miR-107, hsa-miR-532-5p, hsa-miR-26b-5p, hsa-let-7f-5p, …).
  • microparticules


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients treated by radiotherapy and chemotherapy for a glioma stade IV in the Hospital Pitié Salpetreière or in the Paul Strauss hospital from April 2015 to April 2017 will be included.
Criteria

Inclusion Criteria:

  • - diagnosis of glioma (stage 3 to 4)
  • both genders
  • age > 18 years
  • treatment by radiotherapy and chemotherapy
  • clinical monitoring post radiotherapy in Neurology Department, Pitié-Salpêtrière University Hospital and in the radiotherapy department of the Paul Strauss Institute.

Exclusion Criteria:

  • - other neurological tumors and brain metastases
  • psychiatric severe illness, including severe depression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544178


Contacts
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Contact: marie odile bernier, Dr 0033158357225 marie-odile.bernier@irsn.fr
Contact: damien Ricard, Pr 0 33 1 40 51 41 05 damien.ricard@m4x.org

Locations
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France
Hopital Pitié Salpétriere Recruiting
Paris, France, 75013
Contact: Dimitri psimaras, Dr    0033142160403    dimitri.psimaras@psl.aphp.fr   
Contact: marie odile bernier, Dr    0033158357225    marie-odile.bernier@irsn.fr   
Centre paul Strauss Not yet recruiting
Strasbourg, France, 67065
Contact: georges Noel, pr    0033388252485    gnoel@strasbourg.unicancer.fr   
Sponsors and Collaborators
Sophie JACOB
Centre National de la Recherche Scientifique, France
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sophie JACOB, Dr, Institut de Radioprotection et de Surete Nucleaire
ClinicalTrials.gov Identifier: NCT02544178    
Other Study ID Numbers: IRSN_02
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Keywords provided by Sophie JACOB, Institut de Radioprotection et de Surete Nucleaire:
radiotherapy
neurocognitive defect
leukoencephalopathy
Additional relevant MeSH terms:
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Glioblastoma
Leukoencephalopathies
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases