Venous Thromboembolism Clinical Trial
Official title:
Construction and External Validation of a Predictive Clinico-biological Score of the Risk of Venous Thrombosis in Women Under Combined Oral Contraceptives
the investigators hypothesize that some of these polymorphisms contribute to VTE risk in
women using COC, and that their screening could to help assess individual risk of VTE before
COC prescription.
In order to test this hypothesis the investigators propose to build a predictive score for
VTE in women using COC based on clinical and biological factors. To this end the
investigators have a large case study (including 766 patients) recruited at the "Centre
d'Exploration des Pathologies Hémorragiques et Thrombotiques" (CEHT) of the laboratory of
Hematology (La Timone Hospital, Marseille) between 2003 and 2013. The cases had a personal
history of documented VTE while using COC (PILGRIM study). A great number of clinical and
biological relevant phenotypes in the field of VTE have already been collected (including 14
polymorphisms selected on the basis of their biological plausibility and the existence
association studies).To our knowledge it is the largest study specifically conducted in order
to assess genetic factors associated with VTE in women using COC. These 766 cases will be
compared to 766 controls from the general population (cohort Nutrinet-Santé). Then, the
predictive values of the score will be assessed in an independent multicentric validation
study that the investigators will set up in the field of this project. Our study should allow
a better understanding of the genetic and environmental factors involved in VTE related to
COC use. Besides, this project aims to respond to a major public health issue giving an
effective tool for the decision of prescribing COC.
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