PAEDIATRIC IBD (MICI PEDIATRIQUE) - Cohort of Children with IBD (Inflammatory Bowel Disease)
Head :
Colombel Jean-Frédéric, REGISTRE EPIMAD
Gower-Rousseau Corinne
Gower-Rousseau Corinne
Last update : 08/03/2015 | Version : 2 | ID : 60126
| General | |
| Identification | |
| Detailed name | Cohort of Children with IBD (Inflammatory Bowel Disease) |
| Sign or acronym | PAEDIATRIC IBD (MICI PEDIATRIQUE) |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CPP no.: 2007/32 and AFSSAPS no.: 2007-A00468-45 |
| General Aspects | |
| Medical area |
Immunology Radiology and medical imaging Rare diseases |
| Health determinants |
Genetic |
| Keywords | inflammatory diease, hospitalisation, treatment, complications, death |
| Scientific investigator(s) (Contact) | |
| Name of the director | Colombel |
| Surname | Jean-Frédéric |
| Address | 59037 LILLE CEDEX |
| Phone | +33 (0)3 20 44 47 14 ou +33 (0)3 20 44 59 62 |
| jfcolombel@chru-lille.fr ou jean-frederic.colombel@chru-lille.fr | |
| Unit | REGISTRE EPIMAD |
| Name of the director | Gower-Rousseau |
| Surname | Corinne |
| Phone | +33 (0)3 20 44 55 18 |
| corinne.gower@gmail.com | |
| Collaborations | |
| Others | Other related cohorts: some general population paediatric cohorts, particularly in Scandinavia and Scotland. |
| Funding | |
| Funding status |
Mixed |
| Details | Clinical research hospital programme. Association François-Aupetit (patients' association). |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CENTRE D'INVESTIGATION CLINIQUE DU CHRU DE LILLE |
| 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 carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Retrospective. Other bodies active in creating this cohort: CHU, CHG, Independent physicians. Closing date for inclusion: 01/12/2004. |
| Database objective | |
| Main objective |
To study the correlations between phenotypic peculiarities in patients (onset of IBD, disease progression, treatment response), ASCA and ANCA serological markers and allelic status of NOD2/CARD15 gene.
Secondary objectives: - to analyse therapeutic management and surgical predictors for each UC and CD group; - to investigate the development of paediatric forms in adulthood in terms of growth (Z score) and socio-professional level (level of education, age and category of last diploma, current profession); - to establish a database to evaluate the impact of other genetic polymorphisms in order to investigate possible epistasis of these polymorphisms with CARD15/NOD2. |
| Inclusion criteria |
The cohort consists of children with certain or probable Crohn's Disease (CD) or certain or probable ulcerative colitis (UC) identified in the EPIMAD registry between 1988 and 2002.
Children: under 17 years old at the time of diagnosis |
| 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 | Départements: Nord, Pas-de-Calais, Somme, and Seine-Maritime (5.8 million inhabitants) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/1988 |
| Date of last collection (YYYY or MM/YYYY) | 2011 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 698 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Declarative data Paraclinical data Biological data |
| Declarative data (detail) |
Face to face interview |
| Details of collected declarative data | Information sheet at baseline and throughout follow-up (every year) completed by the specialist physician/researching physician. Information collected: -clinical, -radiological, -endoscopic, -weight, -height, -treatment. |
| Paraclinical data (detail) | Imaging: x-ray of small intestine, colon, ultrasound, enteric MRI, etc. Digestive endoscopy and histology. |
| Biological data (detail) | - 2 tubes of 7 ml of blood collected by EDTA for DNA extraction (frozen directly at –20°c); 1 tube of 5 ml of blood in dry tube. Serum is frozen at –20°c for determining serological markers. |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum DNA |
| Details of biobank content | Serum bank, DNA bank |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Clinical examinations: handwritten with double-data entry. |
| Quality procedure(s) used | Consistency request upon entering computer data and following collection of computer data. Management of missing data by returning to source file and/or returning to general practitioner. Physician reminder for follow-up visits. Internal quality audit carried out once a year. Patients are informed about the use of their data. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Every 3 months when encountering experts within the pathology registry (incidence). |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | Pathology registry |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | To be decided if data may be used by academic teams: comparison and validation of data with other IBD cohorts (USA, Norway). Data may not be used by industrial teams. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
