ITMO public health
Last update : 06/24/2015 | Version : 1 | ID : 5972
| General | |
| Identification | |
| Detailed name | Enteric Neuropathy |
| Sign or acronym | NEUROPATHIE ENTERIQUE (ENTERIC NEUROPATHY) |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Date of receipt favourable opinion from CNIL: 01/01/2008 |
| General Aspects | |
| Medical area |
Gastroenterology et hepatology Neurology |
| Health determinants |
Genetic |
| Keywords | phenotypic data, demographic data, computerised data bank, biotherapy, steroid dependence, rheumatic, skin, eye and vascular extra-digestive symptoms, hospital stays, immunosuppressants, health events, consultation, diagnosis, surgery, liver |
| Scientific investigator(s) (Contact) | |
| Name of the director | Bourreille |
| Surname | Arnaud |
| Address | 44093 NANTES CEDEX |
| Phone | + 33 (0)2 40 08 31 52 ou +33 (0)2 40 08 79 25 |
| arnaud.bourreille@chu-nantes.fr | |
| Unit | INSTITUT DES MALADIES DE L’APPAREIL DIGESTIF (IMAD). SERVICE DE GASTRO-ENTEROLOGIE ET D’ASSISTANCE NUTRITIONNELLE. |
| Organization | UMR INSERM U913 CHU |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | CHU Nantes DRCI (Clinical Research and Innovation Delegation) and AAP DHOS-INSERM |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU Nantes |
| 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 as part of an interventional study |
No |
| Additional information regarding sample selection. | Prospective Other bodies active in creating this cohort: CHU, INSERM UMR 913 AND CIC-04 GASTROESOPHAGEAL NUTRITION AND NEUROLOGY FIELD |
| Database objective | |
| Main objective |
General objective: to develop and expand the cohort and enteric neuropathy biological collection for patients with IBD and Parkinson's disease (PD).
Secondary objectives: - Transcriptomic study of neuronal and glial plasticity; - Study and classification of neuro-degenerative processes; - Correlation of neuronal damage with clinical parameters and outlook. |
| Inclusion criteria | Enrolment includes all adult patients with IBD and PD monitored by the CHU in Nantes. Patients will be enrolled at time of diagnosis. Patients will be enrolled after disease diagnosis if phenotypic data included in the database are available in the source file. Blood will be taken during sampling in order to monitor patient disease. Biopsy samples will be taken during endoscopic examinations for conventional disease monitoring. Exclusion criteria: underage patients, absence of study participation consent, lost to follow-up, phenotypic data not available from source file, PD patients with no digestive disorder requiring an endoscopy. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
Regional |
| French regions covered by the database |
Pays de la Loire |
| Detail of the geography area | Pays de la Loire region |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 100 IBD patients and 30 PD patients were included in the biological collection. These patients are part of the historical cohort. Phenotypic data is entered in the electronic database. |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Clinical examination at baseline and every 6 months during follow-up. Information collected during clinical examination: items are filled out during interview. Items correspond to those in the database. Patients are followed up every 6 months and an interview is carried out at every additional visit. Item details were previously entered. |
| Declarative data (detail) |
Face to face interview |
| Details of collected declarative data | Interview questionnaire at baseline and every 6 months during follow-up. |
| Biological data (detail) | Type of samples taken: blood samples (serum 10 ml and 10 ml whole blood) colonic (x6) and/or gastroesophageal biopsies (x4) |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Tissues DNAc/RNAm |
| Details of biobank content | Serum bank, tissue bank, cNAD from colonic biopsy tRNA |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medicines consumption |
| Procedures | |
| Data collection method | Interview: direct input Clinical examinations: direct input Biological analysis: direct input |
| Quality procedure(s) used | Consistency request after electronic data is recorded. Missing data is managed by returning to source file. Physician reminder for follow-up visits. Subject reminder for follow-up visits. Annual internal quality audit of database with 10% file analysis. Patients are informed about the use of their data. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | (Indefinite duration) |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) |
Data may be used by academic teams.
Access conditions for biological collection are part of the Biobanque Ouest Atlantique (BOA, Western Atlantic Biobank) pending GIS-IBiSA certification request. Data will be available to other institutional research teams under contract. Data may be used by industrial teams. Access conditions for biological collection are part of the Biobanque Ouest Atlantique (BOA, Western Atlantic Biobank) pending GIS-IBiSA certification request. Data will be available to other private research teams under contract with CHU. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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