NCT01960751: CogRad

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

Completed NA Last updated 23 January 2025

What this trial tests

NA trial testing neurocognitive tests battery in Patients Treated by Radiotherapy with < One Gy to the Brain in 150 participants. Completed in 4 February 2015.

Timeline

14 April 2014

Primary endpoint
4 February 2015

4 February 2015

Quick facts

Lead sponsor	Institut National de la Santé Et de la Recherche Médicale, France
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	150
Start date	14 April 2014
Primary completion	4 February 2015
Estimated completion	4 February 2015
Sites	1 location across France

Drugs / interventions tested

• neurocognitive tests battery

Conditions studied

• Patients Treated by Radiotherapy with < One Gy to the Brain — all drugs for Patients Treated by Radiotherapy with < One Gy to the Brain →

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France — full company profile →

Who can join

18 and older, any sex, with Patients Treated by Radiotherapy with < One Gy to the Brain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.