ITMO public health
Last update : 07/22/2015 | Version : 2 | ID : 5419
| General | |
| Identification | |
| Detailed name | Patients who did not relapse after stopping tyrosine kinase inhibitor treatment for chronic myeloid leukaemia |
| Sign or acronym | Les STIMS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n°1245229 |
| General Aspects | |
| Medical area |
Immunology |
| Keywords | Tyrosine kinase inhibitors, stopping treatment, complete molecular remission, relapse. |
| Scientific investigator(s) (Contact) | |
| Name of the director | Mahon |
| Surname | François-Xavier |
| Address | Université Bordeaux Ségalen, 146 rue Léo Saignat, 33076 BORDEAUX |
| Phone | + 33 (0)5 57 57 15 24 |
| Francois-Xavier.Mahon@u-bordeaux2.fr | |
| Unit | Hématopoïèse Leucémique et Cible thérapeutiques |
| Organization | Université Bordeaux |
| Name of the director | Bouvier |
| Surname | Séverine |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | PHRC 2006 |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Université Bordeaux Ségalen |
| Organisation status |
Public |
| 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. | Subjects meeting inclusion and exclusion criteria must sign a consent |
| Database objective | |
| Main objective | To monitor patients who discontinued tyrosine kinase inhibitors for at least two years in order to determine their molecular status and collate potential late molecular relapses. |
| Inclusion criteria | Men or women aged 18 years and older Chronic myeloid leukaemia in chronic or accelerated phase under treatment with Imatinib for at least 3 years Complete molecular remission under treatment with Imatinib for at least 2 years For the women old enough to procreate, a method of effective contraception Subjects covered by or affiliated with a social security scheme Negative HIV serology and absence of chronic hepatitis B or C Free and informed consent in writing Molecular monitoring as recommended by European "LeukemiaNet" |
| 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 |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2010 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 100 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Medical registration |
| Biological data (detail) | BCR-ABL transcript level |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Data collection method | After the accuracy of the data is verified, they are collected by mail or directly on site by the person in charge of verification every 3-6 months. The same person enters the data in an Access database, which is then transferred to a biostatistician. This is done centrally. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | The BCR-ABL transcript level is measured by quantitative RT-PCR in molecular biology laboratories every 3 months following a blood sample from the patient. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Pubmed-STIMS |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Publications Data are accesible by other researchers by request if required (via secure Excel files graphics, etc.) |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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