ITMO public health
Last update : 09/16/2015 | Version : 1 | ID : 60
| General | |
| Identification | |
| Detailed name | FranceCoag Network |
| Sign or acronym | FCN |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL authorisation no.: 903272 |
| General Aspects | |
| Medical area |
Hematology Rare diseases |
| Pathology (details) | hereditary hemorrhagic diseases (except platelet disorders) |
| Health determinants |
Genetic Geography Medicine |
| Keywords | haemophilia, von Willebrand disease, national registry, inhibitor, hereditary hemorrhagic diseases, replacement therapy; prophylaxis |
| Scientific investigator(s) (Contact) | |
| Name of the director | Goulet |
| Surname | Véronique |
| Address | 12, rue du Val d’Osne 94415 Saint-Maurice |
| Phone | + 33 (0)1 55 12 53 09 |
| v.goulet@invs.sante.fr | |
| Unit | Département des maladies chroniques et traumatismes |
| Organization | INVS - Institut de Veille Sanitaire |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | Participation in the World Federation of hemophilia (WFH) |
| Funding | |
| Funding status |
Public |
| Details | Ministry of Health |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INVS - Institut de Veille Sanitaire |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Morbidity registers |
| Study databases (details) |
Cohort study |
| Additional information regarding sample selection. | None because of national registry. |
| Database objective | |
| Main objective |
Four objectives:
1) Thorough knowledge of the epidemiological characteristics of hereditary haemorrhagic diseases ; 2) To monitor the health of this population; 3) To know the risk factors of inhibitor's development (treatment side effect) and their therapeutic managment; 4) To assess the impact of preventive treatment and contribute to improving the quality of healthcare. |
| Inclusion criteria |
Patients with:
- Hemophilia A or B with factor VIII (FVIII) or factor (FIX) <40%; - Type 1 von Willebrand disease (VWD) with VWF:Ag <30%; Type 2 with a VWF:RCo/VWF:Ag ratio <0.7 or VWF:CB/VWF:Ag <0.7 or FVIII:C/VWF:Ag < 0.5 or positive RIPA; Type 3 with VWF:Ag and VWF:RCo <5%; - Afibrinogenemia (fibrinogen < 0.2 g / l); - a deficiency in factor FII, FV, FVII, FX, FXIII <10%, FXI <20% or FV + FVIII <30%. |
| 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) Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Patients are included throughout the national territory and monitored by 36 haemophilia treatment centres (HTC). |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 1994 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 9,288 patients enrolled on 07/09/2015. |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Paraclinical data Biological data |
| Clinical data (detail) |
Medical registration |
| Paraclinical data (detail) | Score PedNet (joint score) |
| Biological data (detail) | Deficient factor base rate, inhibitor research assessment, etc. |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Plasma Blood cells isolated |
| Details of biobank content | A Biobank was established between 1994 and 2002 and between 2008 and 2011. This includes blood samples (mononuclear cells, plasma, serum). The Biobank was stopped at the end of 2011. |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Others |
| Care consumption (detail) |
Medicines consumption |
| Other (detail) | Genetics, ethnic origin |
| Procedures | |
| Data collection method | Data are gathered through electronic forms by clinicians following patients in 36 haemophilia treatment centres throughout the national territory. |
| Classifications used | Coding conventions specific to project. |
| Quality procedure(s) used | Data monitoring conducted by 3 clinical research associates. Data are checked: - at the coordination centre by automatically processing collected data after recording (missing data, outliers and inconsistent data) - in treatment centres against clinical files on 100% of forms: General cohort (on a selection of items); PUPS sub-cohort (all data). |
| Participant monitoring |
Yes |
| Details on monitoring of participants | No follow-up schedule imposed by clinicians; No controlled treatment; No specific examination; Only one recommandation: patient's data sent on an annual (general cohort) or quarterly basis (PUPS sub-cohort = patients with severe hemophilia). |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.francecoag.org/SiteWebPublic/html/documentsTele.html |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Access to operation results on the database through webFC, dedicated RFC computer application (http://www.francecoag.org). Database is accessible to all internal or external researchers interested in the project after submitting a project to 2 experts that is validated by members of the RFC Steering Committee. |
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