Clinical trial NCT01960751: Long Term Neurocognitive Effects of Low-dose Radiation in the Brain: Study of 150 Patients in the French Hemangioma Cohort
Official title: Etude Des Séquelles Neurocognitives À Long Terme Des Faibles Doses De Radiation Chez 150 Patients Traités Par Radiothérapie Dans L'enfance Pour Un Hémangiome Cutané À L'Institut Gustave Roussy (IGR) Entre 1941 Et 1973
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Treated by Radiotherapy with < One Gy to the Brain
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: European Commission
name: Gustave Roussy, Cancer Campus, Grand Paris
First posted: 2013-10-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Context: Studies that address specifically the neurocognitive consequences that can be caused by low-dose radiation receiving during the childhood have still to be performed. In this issue, we focus on an investigation with patients who have received radiotherapy for a benign tumor (skin hemangioma), in France.

Patients and methods: More than 8300 children with a skin hemangioma were treated at Gustave Roussy (Île-de-France) from 1941 to 1973 and a number of them have received radiotherapy. These patients have been treated and followed by Gustave Roussy, so their clinical records can be tracked with great accuracy and the ionizing radiation dose to the brain have been estimated. From this patient cohort, the aim is to evaluate neurocognitive dysfunction or disorder that can be caused by low-dose radiation to the brain (less than one Gray (Gy)). A total of 150 patients is expected. They will be contacted by letter to explain the purpose and methods of carrying out tests. Two groups will be analysed according to the received ionizing radiation dose to the brain during the radiotherapy (exposed: 0.05 to 1 Gy, vs unexposed: less than 0.05 Gy). Tests exploring several cognitive functions (memory, arithmetic, orientation, etc.) will be used.

Expected results: We expect to describe the potential neurocognitive dysfunction or disorder and to identify risk factors and brain structures whose lesions are responsible for the neurocognitive dysfunction or disorder.

A therapeutic treatment will be proposed in the eventuality of screening of a neurocognitive dysfunction or disorder.

Detailed description: CogRad is an interventional study designed within the European project called Cognitive and Cerebrovascular Effects Induced by Low Dose Ionizing Radiation (CerebRad).

CerebRad is a collaborative European project funded in 2011 within the 7th European Union (EU) framework programme, Nuclear Fission and Radiation Protection. CerebRad aims to identify the potential cognitive and cerebrovascular risks of radiation doses below 100 milliGray (mGy) when delivered to a young child (pre- or postnatally).

Eligibility criteria: Inclusion Criteria:

* Subject treated by radiotherapy for a skin hemangioma in childhood at Gustave Roussy between 1941 and 1973 and who have received less than 1 Gy of radiation doses in the brain
* Inhabitants of Île-de-France
* French medical insurance
* Good knowledge and understanding of the French language

Non-inclusion Criteria

* Cerebral hemangioma
* Syndrome genetic predisposition
* Pregnant woman
* Private person of liberty or under guardianship
* Radiation dose to the brain greater than 1 Gy during radiotherapy treatment of skin hemangioma
* Chemotherapy during skin hemangioma treatment
* Inability to undergo counseling for geographical reasons

Exclusion Criteria:

* Pregnancy
* Inability to perform neurocognitive tests battery for medical reasons

Primary outcomes:
measure: All neurocognitive dysfunction or disorder on adults measured by means of eight tests
timeFrame: Participants will be tested for the duration of hospital stay (half a day).The neurocognitive tests battery will be carry out 56 years on average after exposure to low-dose radiation.
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: Gustave Roussy, France
name: Chiraz EL-FAYECH
role: STUDY_DIRECTOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Florent DE VATHAIRE
role: STUDY_DIRECTOR
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