Study of Neurological Complication After Radiotherapy for High Grade Glioblastoma (EPIBRAINRAD)
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|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
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|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
neurocognitive tests before and after radiotherapy
Radiation: brain radiotherapy
effect of cerebral radiotherapy on neurocognitive state
- decrease of 1.5 SD of Compurerized Speed Cognitive test [ Time Frame: before radiotherapy, at 12 and 36 months ]
- 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.
- 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.
- 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
- 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, …).
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
|Contact: marie odile bernier, Dremail@example.com|
|Contact: damien Ricard, Pr||0 33 1 40 51 41 firstname.lastname@example.org|
|Hopital Pitié Salpétriere||Recruiting|
|Paris, France, 75013|
|Contact: Dimitri psimaras, Dr 0033142160403 email@example.com|
|Contact: marie odile bernier, Dr 0033158357225 firstname.lastname@example.org|
|Centre paul Strauss||Not yet recruiting|
|Strasbourg, France, 67065|
|Contact: georges Noel, pr 0033388252485 email@example.com|