ITMO public health
Last update : 07/06/2014 | Version : 1 | ID : 5615
| General | |
| Identification | |
| Detailed name | Prescription and Utilisation of Low Molecular Weight Heparin (LMWH) in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism (VTE) in Patients With Cancer. |
| Sign or acronym | TROPIQUE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n° 912315 (31/12/12), CCTIRS dossier 12335 (07/06/12) |
| General Aspects | |
| Medical area |
Cancer research General practice |
| Others (details) | Thromboembolism, cancer |
| Keywords | Venous thromboembolism, Cancer, LMWH |
| Scientific investigator(s) (Contact) | |
| Name of the director | Lamblin |
| Surname | Anne |
| Address | LEO Pharma France - 6 rue Jean-Pierre Timbaud - 78180 MONTIGNY LE BRETONNEUX |
| Phone | + 33 (0)1 30 14 40 00 |
| anne.lamblin@leo-pharma.com | |
| Unit | LEO Pharma France |
| Organization | LEO Pharma |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | LEO Pharma |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Laboratoire LEO pharma |
| 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. | Patients meeting inclusion and exclusion criteria are included consecutively in the study. |
| Database objective | |
| Main objective | To document the prescription and the use of LMWH in usual medical practice in France for the treatment of symptomatic VTE in patients with cancer. To assess the conformity of LMWH usage with national recommendations (www.sor-cancer.com et www.thrombose-cancer.com) for VTE treatment in patients with cancer. To evaluate thromboembolism recurrence, bleeding, thrombocytopenia and death as well as document the reasons for discontinuing treatment. To describe clinical factors associated with LMWH treatment duration and those associated with the occurrence of VTE in patients with cancer. To evaluate anticoagulant treatment perception in cancer patients in order to have a better knowledge of their LMWH treatment satisfaction. |
| Inclusion criteria | - Men or women aged 18 years or more. Patients who have given oral consent to participate after receiving oral and written information concerning the study. Patients with a solid or liquid tumour confirmed by a histological or cytological examination and receiving anti-cancerous therapy or palliative care. Patients diagnosed with venous thromboembolism (VTE) defined as: - symptomatic proximal or distal deep vein thrombosis (DVP) - confirmed pulmonary embolism (PE) - visceral embolism - thrombosis from a long-term central venous catheter. Patients who have begun curative VTE treatment with LMWH for 7 days or more. Exclusion criteria: Patients treated with LMWH for more than 7 days. Patients presenting contraindications to LMWH use confirmed by respective multidisciplinary meetings. |
| 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) | 11/2012 |
| Date of last collection (YYYY or MM/YYYY) | 01/2014 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 155 (21/03/2013) |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Medical registration |
| Declarative data (detail) |
Face to face interview |
| 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 | A satisfaction questionnaire regarding LMWH treatment will be completed by the patient at baseline and at the end of their treatment. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Data on LMWH treatment and different clinical parameters will be gathered at baseline and at 3-month and 6-month follow-up. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/25099690 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | All requests to be sent to LEO Pharma |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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