COCCINELLE - Cohorte sur le risque de cancer après cardiologie interventionnelle pédiatrique

Head :
Baysson Hélène, Laboratoire d'Epidémiologie
Bernier Marie-Odile, Laboratoire d'Epidémiologie
Laurier Dominique, Laboratoire d'Epidémiologie

Last update : 07/08/2015 | Version : 2 | ID : 6330

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name Cohorte sur le risque de cancer après cardiologie interventionnelle pédiatrique
Sign or acronym COCCINELLE
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation autorisation CNIl n°911112, Décembre 2011
General Aspects
Medical area Cancer research
Cardiology
Keywords ionizing radiation, interventional cardiology, cancer, children
Scientific investigator(s) (Contact)
Name of the director Baysson
Surname Hélène
Address IRSN -PRP-hom\SRBE - BP17 - 92260 Fontenay aux Roses
Phone + 33 (0)1 58 35 96 30
Email helene.baysson@irsn.fr
Unit Laboratoire d'Epidémiologie
Organization IRSN
Name of the director Bernier
Surname Marie-Odile
Address IRSN -PRP-hom\SRBE - BP17 - 92260 Fontenay aux Roses
Phone + 33 (0)1 58 35 72 25
Email marie-odile.bernier@irsn.fr
Unit Laboratoire d'Epidémiologie
Organization IRSN
Name of the director Laurier
Surname Dominique
Address IRSN -PRP-hom\SRBE - BP17 - 92260 Fontenay aux Roses
Phone + 33 (0)1 58 35 89 99
Email dominique.laurier@irsn.fr
Unit Laboratoire d'Epidémiologie
Organization IRSN
Collaborations
Funding
Funding status Public
Details IRSN, INCa
Governance of the database
Sponsor(s) or organisation(s) responsible IRSN (Institut de radioprotection et de sûreté nucléaire)
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
Database objective
Main objective Children with congenital heart disease frequently undergo cardiac catheterization procedures for diagnostic or treatment purposes. Despite the clear clinical benefit to the patient, the complexity of these procedures may result in high cumulative radiation exposure. Given children's greater sensitivity to radiation and the longer life span during which radiation health effects can develop, an epidemiological cohort study, named Coccinelle (Cohorte sur le risque de cancer après cardiologie interventionnelle pédiatrique) is being launched in France to evaluate the risks of leukaemia and solid cancers in this specific population.
Inclusion criteria The study population will include all children who have undergone at least one cardiac catheterization procedure since 2000 and were under 10 years old and permanent residents of France at the time of the procedure. Electronically stored patient records from the departments of paediatric cardiology of the French national network for complex congenital heart diseases (M3C) are being searched to identify the children to be included.
Population type
Age Newborns (birth to 28 days)
Infant (28 days to 2 years)
Early childhood (2 to 5 years)
Childhood (6 to 13 years)
Adolescence (13 to 18 years)
Population covered Sick population
Gender Male
Woman
Geography area National
Detail of the geography area The minimum dataset will comprise: identification of the subject, characteristics of the procedure and technical details, such as fluoroscopy time and dose area product (DAP), which are needed to reconstruct the doses received by each child. The cohort will be followed up through linkage with the two French paediatric cancer registries, which record all cases of childhood leukaemia and solid cancers in France. Radiation exposure will be estimated retrospectively for each child included in the cohort. Organ doses, especially to the lung, the oesophagus, and the thyroid will then be calculated with PCXMC software.
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 01/2011
Date of last collection (YYYY or MM/YYYY) 12/2014
Size of the database
Size of the database (number of individuals) [1000-10 000[ individuals
Details of the number of individuals 8000
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) clinical data
Administrative data (detail) administrative data
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Procedures
Participant monitoring Yes
Links to administrative sources Yes
Promotion and access
Promotion
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/?term=%28%28Baysson[Author]+OR+Bernier[Author]+OR+Laurier[Author]%29+AND+%28coccinelle+OR+ladybird%29%29+OR+23521893[uid]
Description List of publications in Pubmed
Access
Terms of data access (charter for data provision, format of data, availability delay) none
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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