TARC-ABPA - Study of Th2/Th17 balance during allergic bronchopulmonary aspergillosis
Head :
Magnan Antoine, L'INSTITUT DU THORAX - INSERM UMR1087 / CNRS UMR 6291
Last update : 06/11/2013 | Version : 1 | ID : 60166
| General | |
| Identification | |
| Detailed name | Study of Th2/Th17 balance during allergic bronchopulmonary aspergillosis |
| Sign or acronym | TARC-ABPA |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CPP n° 2012-R6 03/2013 ; Afsapps |
| General Aspects | |
| Medical area |
Pneumology Study of allergies |
| Health determinants |
Genetic |
| Keywords | allergic bronchopulmonary aspergillosis, exacerbations, biomarkers |
| Scientific investigator(s) (Contact) | |
| Name of the director | Magnan |
| Surname | Antoine |
| Address | 44000 NANTES |
| Phone | + 33 (0)2 28 08 01 26 |
| antoine.magnan@univ-nantes.fr | |
| Unit |
L'INSTITUT DU THORAX - INSERM UMR1087 / CNRS UMR 6291 |
| Organization | INSERM / CHU DE |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | DRASS PAYS DE LA LOIRE IRSR pays de loire |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU DE 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 by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
Yes |
| Details |
Performed at individual level |
| Additional information regarding sample selection. | Perspective cohort. End of inclusions: 01/06/2014 |
| Database objective | |
| Main objective | Evaluate the relevance of new biomarkers for monitoring allergic bronchopulmonary aspergillosis : study of changes in exhaled NO, induced sputum cellularity, Aspergillus serology by ELISA method lymphocyte populations. |
| Inclusion criteria |
ABPA diagnostic: total IgE superior to 417 KU/L immediat hypersensitivity to Aspergillus (positive prick-test and/or positive specifics ige) proximal DDB (bronchiectasis) and/or labile infiltrate (ABPA-S) positives anti-aspergillosis precipitins. Patients pre-included : legally adults, either gender; members of a social security system, obligatory informed and written consent, carriers of an ABPA with all the criteria set out hereinafter, at least once in their medical file; patients without exacerbation since V0 or V0', allowing the definition of a basic status. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 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 | French Multicentric cohort (3 centers) : Nantes, Angers, Le Mans |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 06/2012 |
| Date of last collection (YYYY or MM/YYYY) | 06/2014 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 30 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Face to face interview |
| Biological data (detail) | At each exam: induced expectoration (only at the Nantes center), blood sample (improved total IgE test, specifics, IgC…)ECBC |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Blood cells isolated DNA DNAc/RNAm |
| Details of biobank content | Serum, blood cells, DNA, RNA bank |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | Self-questionnaire : manually filled paper questionnaire with double data entry. Interviews: entry from a paper form (manually filled) with double entry. Clinical examinations : direct entry Biological examinations direct computer entry |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration : 2 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data utilization by academic teams te be determined. Data utilization not available for industry sectors. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
