CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 119 enrolled
Drug / intervention
neurocognitive tests batteryother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01960751
NCT01960751N/ACompleted

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

Institut National de la Santé Et de la Recherche Médicale, France·interventional·Posted Oct 11, 2013·Updated Apr 23, 2026

In Brief

A clinical study evaluating neurocognitive tests battery for Patients Treated by Radiotherapy With < One Gy to the Brain. Completed, enrolled 119 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 11, 2013
Enrollment StartApr 14, 2014
Primary CompletionFeb 4, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.7 years ago

Interventions

neurocognitive tests batteryother

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