Long Term Neurocognitive Effects of Low-dose Radiation in the Brain: Study of 150 Patients in the French Hemangioma Cohort

NCT01960751 | Completed

• 2 other identifiers: C13-012013-A00513-42
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Treated by Radiotherapy With < One Gy to the Brain

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

neurocognitive tests

OTHER

neurocognitive tests battery (MMSE, SDS, SF-36, HAD, BPRS, RAVLT, FACT-Cog, MoCA)

Other: neurocognitive tests battery

Interventions

neurocognitive tests battery OTHER

The two groups (exposed: 0.05 to 1 Gy; unexposed: less than 0.05 Gy) will receive the same neurocognitive tests battery.

Also known as: - MMSE, - SDS, - SF-36, - HAD, - BPRS, - RAVLT, - FACT-Cog, - MoCA

neurocognitive tests

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• European Commission: collaborator
• Gustave Roussy, Cancer Campus, Grand Paris: collaborator

Study Sites (1)

Gustave Roussy

Villejuif, France

Location

Related Publications (9)

• 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.

  PMID: 1835589 BACKGROUND

• 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.

  PMID: 3173432 BACKGROUND

• 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.

  PMID: 2034788 BACKGROUND

• 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.

  PMID: 14703539 BACKGROUND

• 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.

  PMID: 19515442 BACKGROUND

• 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.

  PMID: 22082956 BACKGROUND

• 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.

  PMID: 20607383 BACKGROUND

• 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.

  PMID: 15236880 BACKGROUND

• 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.

  PMID: 10075261 BACKGROUND

MeSH Terms

Interventions

Mental Status and Dementia Tests

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Chiraz EL-FAYECH

  Gustave Roussy, France

  STUDY DIRECTOR

• Florent DE VATHAIRE

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: October 11, 2013
• Study Start: April 14, 2014
• Primary Completion: February 4, 2015
• Study Completion: February 4, 2015
• Last Updated: April 23, 2026

Record last verified: 2025-01

Locations

FR (1)