ITMO public health
Last update : 06/30/2014 | Version : 1 | ID : 8166
| General | |
| Identification | |
| Detailed name | Cohort on Iatrogenic Risks Associated with CT Scans Received in Childhood |
| Sign or acronym | TOMENF2 |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL n°1347141 |
| General Aspects | |
| Medical area |
Cancer research Cardiology Neurology Ophthalmology Radiology and medical imaging |
| Health determinants |
Iatrogenic |
| Others (details) | Cancer, cardiovascular and cerebrovascular disease, cataracts |
| Keywords | Tomography, dose-effect relationship, CT scan, ionising radiation, iatrogenic effects, dosimetry |
| Scientific investigator(s) (Contact) | |
| Name of the director | Rubino |
| Surname | Carole |
| Address | 114, rue Édouard Vaillant 94805 Villejuif Cedex |
| Phone | +33 (0)1 42 11 62 33 |
| carole.rubino@gustaveroussy.fr | |
| Unit | Team 3-CESP - Unit 1018 INSERM / IGR |
| Organization | INSERM |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | - INSERM - Commission Européenne - EDF Recherche de financements additionnels |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Only University Hospitals Centres with computerised data will be considered. Subjects admitted to one of these centres and meeting the required inclusion criteria were selected. |
| Database objective | |
| Main objective | The objective is to form a multicentric cohort of 30,000 children admitted to radiology departments in France in order to describe the pattern of computerised tomography use during childhood and to estimate the dosage associated with these examinations. This cohort will later explore the iatrogenic effects of low-dosage of ionising radiation, carcinogenic and non-carcinogenic effects. |
| Inclusion criteria | - Children under 15 years old admitted to radiology services for initial examination after 1st January 2000 - Children permanently living in France - not diagnosed with cancer during first year after computerised tomography (CT) scan. |
| Population type | |
| Age |
Early childhood (2 to 5 years) Childhood (6 to 13 years) Adolescence (13 to 18 years) Adulthood (19 to 24 years) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | University hospitals in Lyon, Caen and Reims at present. Univeristy hospitals in Brest, Rennes, Besançon, Amiens and Dijon pending agreement |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 |
| Size of the database | |
| Size of the database (number of individuals) |
[10 000-20 000[ individuals |
| Details of the number of individuals | 30 000 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Paraclinical data Administrative data |
| Clinical data (detail) |
Direct physical measures |
| Paraclinical data (detail) | Personal information: name, gender, place of birth, date of birth, post code. |
| Administrative data (detail) | INSEE, SNIIRAM |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Medical/paramedical consultation |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | The cohort will be prospectively monitored for cancers (leukaemias and solid tumours) as well as heart disease, cerebrovascular disease and cataracts by cross-referencing data from the National Registry of Solid Tumours and SNIIRAM. The acquisition of vital status and date of death from INSEE data, as well as cause of death will be carried out at the time the cohort is formed and every 5 years. |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | INSEE, SNIIRAM |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/24670918 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/24419490 |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientific director. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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