Long Term Neurocognitive Effects of Low-dose Radiation in the Brain: Study of 150 Patients in the French Hemangioma Cohort
NCT ID: NCT01960751
Last Updated: 2025-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
150 participants
INTERVENTIONAL
2014-04-14
2015-02-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Irradiation in Paediatrics: Neurocognition, Neuroimaging and Evaluation of Memory and Attention
NCT06599879
Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory
NCT02750371
Cognitive Changes of IDH-mutant and IDH-wildtype Glioma Patients After Chemoradiotherapy With Radiation Dose to the Resting State Networks
NCT04975139
Remote Brain Microhaemorrhages May Predict Haematoma in Glioma Patients Treated With Radiation Therapy
NCT03973892
Multicenter Study on Rehabilitation Medical Data for Pediatric Big Brain Development
NCT06367920
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
neurocognitive tests
neurocognitive tests battery (MMSE, SDS, SF-36, HAD, BPRS, RAVLT, FACT-Cog, MoCA)
neurocognitive tests battery
The two groups (exposed: 0.05 to 1 Gy; unexposed: less than 0.05 Gy) will receive the same neurocognitive tests battery.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
neurocognitive tests battery
The two groups (exposed: 0.05 to 1 Gy; unexposed: less than 0.05 Gy) will receive the same neurocognitive tests battery.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Inhabitants of Île-de-France
* French medical insurance
* Good knowledge and understanding of the French language
* 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
* Inability to perform neurocognitive tests battery for medical reasons
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Commission
OTHER
Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chiraz EL-FAYECH
Role: STUDY_DIRECTOR
Gustave Roussy, France
Florent DE VATHAIRE
Role: STUDY_DIRECTOR
Institut National de la Santé Et de la Recherche Médicale, France
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gustave Roussy
Villejuif, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Fragu P, Lemarchand-Venencie F, Benhamou S, Francois P, Jeannel D, Benhamou E, Sezary-Lartigau I, Avril MF. Long-term effects in skin and thyroid after radiotherapy for skin angiomas: a French retrospective cohort study. Eur J Cancer. 1991;27(10):1215-22. doi: 10.1016/0277-5379(91)90084-q.
Ron E, Modan B, Boice JD Jr, Alfandary E, Stovall M, Chetrit A, Katz L. Tumors of the brain and nervous system after radiotherapy in childhood. N Engl J Med. 1988 Oct 20;319(16):1033-9. doi: 10.1056/NEJM198810203191601.
Little MP, Hawkins MM, Shore RE, Charles MW, Hildreth NG. Time variations in the risk of cancer following irradiation in childhood. Radiat Res. 1991 Jun;126(3):304-16.
Hall P, Adami HO, Trichopoulos D, Pedersen NL, Lagiou P, Ekbom A, Ingvar M, Lundell M, Granath F. Effect of low doses of ionising radiation in infancy on cognitive function in adulthood: Swedish population based cohort study. BMJ. 2004 Jan 3;328(7430):19. doi: 10.1136/bmj.328.7430.19.
Haddy N, Andriamboavonjy T, Paoletti C, Dondon MG, Mousannif A, Shamsaldin A, Doyon F, Labbe M, Robert C, Avril MF, Fragu P, Eschwege F, Chavaudra J, Schvartz C, Lefkopoulos D, Schlumberger M, Diallo I, de Vathaire F. Thyroid adenomas and carcinomas following radiotherapy for a hemangioma during infancy. Radiother Oncol. 2009 Nov;93(2):377-82. doi: 10.1016/j.radonc.2009.05.011. Epub 2009 Jun 8.
Haddy N, Mousannif A, Paoletti C, Dondon MG, Shamsaldin A, Doyon F, Avril MF, Fragu P, Labbe M, Lefkopoulos D, Chavaudra J, Robert C, Diallo I, de Vathaire F. Radiotherapy as a risk factor for malignant melanoma after childhood skin hemangioma. Melanoma Res. 2012 Feb;22(1):77-85. doi: 10.1097/CMR.0b013e32834dcff1.
Haddy N, Dondon MG, Paoletti C, Rubino C, Mousannif A, Shamsaldin A, Doyon F, Labbe M, Robert C, Avril MF, Demars R, Molinie F, Lefkopoulos D, Diallo I, de Vathaire F. Breast cancer following radiotherapy for a hemangioma during childhood. Cancer Causes Control. 2010 Nov;21(11):1807-16. doi: 10.1007/s10552-010-9607-5. Epub 2010 Jul 7.
Dondon MG, de Vathaire F, Shamsaldin A, Doyon F, Diallo I, Ligot L, Paoletti C, Labbe M, Abbas M, Chavaudra J, Avril MF, Fragu P, Eschwege F. Cancer mortality after radiotherapy for a skin hemangioma during childhood. Radiother Oncol. 2004 Jul;72(1):87-93. doi: 10.1016/j.radonc.2004.03.011.
Ligot L, Diallo I, Shamsaldin A, Chavaudra J, BonaIti-Pellie C, de Vathaire F. Individualized phantom based on CT slices and auxological data (ICTA) for dose estimations following radiotherapy for skin haemangioma in childhood. Radiother Oncol. 1998 Dec;49(3):279-85. doi: 10.1016/s0167-8140(98)00099-1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-A00513-42
Identifier Type: REGISTRY
Identifier Source: secondary_id
C13-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.