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

October 8, 2013 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

CogRad is an interventional study designed within the European project called Cognitive and Cerebrovascular Effects Induced by Low Dose Ionizing Radiation (CerebRad).

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).

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Villejuif, France
        • Gustave Roussy
        • Sub-Investigator:
          • Isabelle LEGER
        • Sub-Investigator:
          • Virginie KIEFFER
        • Sub-Investigator:
          • Carole RUBINO
        • Principal Investigator:
          • Cécile THOMAS-TEINTURIER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: neurocognitive tests
neurocognitive tests battery (MMSE, SDS, SF-36, HAD, BPRS, RAVLT, FACT-Cog, MoCA)
Other: 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 Names:
  • - MMSE
  • - SDS
  • - SF-36
  • - HAD
  • - BPRS
  • - RAVLT
  • - FACT-Cog
  • - MoCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All neurocognitive dysfunction or disorder on adults measured by means of eight tests
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

European Commission
Gustave Roussy, Cancer Campus, Grand Paris

Investigators

  • Study Director: Chiraz EL-FAYECH, Gustave Roussy, France
  • Study Director: Florent DE VATHAIRE, Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

August 7, 2013

First Submitted That Met QC Criteria

October 8, 2013

First Posted (Estimate)

October 11, 2013

Study Record Updates

Last Update Posted (Estimate)

October 11, 2013

Last Update Submitted That Met QC Criteria

October 8, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • C13-01
  • 2013-A00513-42 (Registry Identifier: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Patients Treated by Radiotherapy With < One Gy to the Brain

Clinical Trials on neurocognitive tests battery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe