NCT02544178

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

3 years

First QC Date

July 20, 2015

Last Update Submit

September 21, 2016

Conditions

Leukoencephalopathy

Keywords

radiotherapyneurocognitive defectleukoencephalopathy

Outcome Measures

Primary Outcomes (1)

  • decrease of 1.5 SD of Compurerized Speed Cognitive test

    before radiotherapy, at 12 and 36 months

Secondary Outcomes (4)

  • sensitivity and specificity of the Compurerized Speed Cognitive test

    at the inclusion time (before radiotherapy), at 12 and 36 months

  • dosimetric prognostic factors of neurocognitive defects

    at the inclusion time (before radiotherapy), and at 12 and 36 months

  • levels of biomarkers before and after radiotherapy

    at the inclusion time (before radiotherapy), , at 12 and 36 months

  • radiological prognostic factors of neurocognitive defects

    at the inclusion time (before radiotherapy), and at 12 and 36 months

Study Arms (1)

diagnostic procedure

neurocognitive tests before and after radiotherapy

Radiation: brain radiotherapy

Interventions

brain radiotherapyRADIATION

effect of cerebral radiotherapy on neurocognitive state

diagnostic procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital Pitié Salpétriere

Paris, 75013, France

RECRUITING

Centre paul Strauss

Strasbourg, 67065, France

NOT YET RECRUITING

Related Publications (1)

  • Durand T, Jacob S, Lebouil L, Douzane H, Lestaevel P, Rahimian A, Psimaras D, Feuvret L, Leclercq D, Brochet B, Tamarat R, Milliat F, Benderitter M, Vayatis N, Noel G, Hoang-Xuan K, Delattre JY, Ricard D, Bernier MO. EpiBrainRad: an epidemiologic study of the neurotoxicity induced by radiotherapy in high grade glioma patients. BMC Neurol. 2015 Dec 18;15:261. doi: 10.1186/s12883-015-0519-6.

    PMID: 26684198DERIVED

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

MeSH Terms

Conditions

Leukoencephalopathies

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

marie odile bernier, Dr

CONTACT

0033158357225marie-odile.bernier@irsn.fr

damien Ricard, Pr

CONTACT

0 33 1 40 51 41 05damien.ricard@m4x.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 20, 2015

First Posted

September 9, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2018

Study Completion

April 1, 2020

Last Updated

September 22, 2016

Record last verified: 2016-09

Locations

FR(2)