SATURNE - Monitoring of chronic Immune Thrombocytopenia (ITP) treated with thrombopoietin receptor (TPO-R) agonists in France
Head :
Leclerc-Zwirn Christel, GSK
Last update : 09/07/2020 | Version : 1 | ID : 3133
| General | |
| Identification | |
| Detailed name | Monitoring of chronic Immune Thrombocytopenia (ITP) treated with thrombopoietin receptor (TPO-R) agonists in France |
| Sign or acronym | SATURNE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n°911529 |
| General Aspects | |
| Medical area |
Hematology Immunology Rare diseases |
| Scientific investigator(s) (Contact) | |
| Name of the director | Leclerc-Zwirn |
| Surname | Christel |
| Address | 100 ROUTE DE VERSAILLES PARIS |
| Unit | GSK |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Laboratoire GSK |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | LABORATOIRE GSK |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. |
Physician selection:
Identification of the physicians via a sampling base consisting of: - The French Hematologists' Directory, - The list of accredited centers, - Internal Medicine departments, A random sample of 1 000 physicians will be extracted from the base. The database will be previously reduced in order to point physicians who manage ITP of adults. 4.4 Patient sample size ITP is a rare disease. In consequence, calculation of the number of subjects needed is based more on the feasibility of recruitment in an acceptable timeframe than on a hard assessment criterion. In view of the incidence and prevalence of ITP and our estimates, recruitment of 200 patients by 60 to 70 participating physicians (active centers) constitutes a feasible objective. However, given that it is highly probable that the patients treated with TPO-R agonists mainly receive care in reference or accredited centers, the participating physicians will be asked to include 3 to 8 patients at TPO-R |
| Database objective | |
| Main objective | Describing the profile of patients with chronic ITP treated with TPO-R agonists and the clinical course of their disease over 2 years |
| Inclusion criteria |
Each participating physician is to include in a cross-sectional registry the first patients who are managed for their ITP persistent or chronic. Each physician could fill information about 15 patients maximum.
Among the maximum of 15 patients included in the cross-sectional registry, each participating physician is to include in the cohort, in a consecutive manner, the first 3 to 8 patients with chronic ITP at TPO-R agonist treatment initiation in compliance with the inclusion criteria |
| Population type | |
| Age |
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 | FRANCE |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2012 |
| Date of last collection (YYYY or MM/YYYY) | 2014 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 500 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Biological data (detail) | 1. NFS2. Blood film3. TP, TCA, TCK, fibrinogène4. hepatic assessment5. Electrophorèse des protides/protéines6. viral serology: VIH/Hépatitis B and C7. Coombs direct test, ou anti globulin direct test8. Creatinine9. antibody against nuclear endotoxin test10Myelogram |
| Administrative data (detail) | socio-demographic data, socio-professional group, (CSP), ethnic group |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Throughout the study, data acquisition will be implemented via an electronic CRF (e-CRF). In order to analyze the time course of the quality of life and satisfaction of patients with chronic ITP treated with a TPO-R agonist, a quality of life and satisfaction questionnaire will be supplied to the patients taking part in the study |
| Participant monitoring |
Yes |
| Details on monitoring of participants | In order to achieve the primary objective, the physicians will be asked to fill out the e-CRF at time points: M0, M3, M6, M12, M18 and M24 |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Publication |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
