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