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

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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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 test10Myelogram
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

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