Patients Treated by Radiotherapy With < One Gy to the Brain Clinical Trial
— CogRadOfficial 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
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.
| Status | Not yet recruiting |
| Enrollment | 150 |
| Est. completion date | March 2015 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
| Country | Name | City | State |
|---|---|---|---|
| France | Gustave Roussy | Villejuif |
| Lead Sponsor | Collaborator |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | European Commission, Gustave Roussy, Cancer Campus, Grand Paris |
France,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | All neurocognitive dysfunction or disorder on adults measured by means of eight tests | The score to the 8 tests will be correlate with the presence of neurocognitive dysfunction or disorder | 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. | No |