Construction and External Validation of a Predictive Clinico-biological Score of the Risk of Venous Thrombosis in Women Under Combined Oral Contraceptives (PILGRIM)

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Venous Thromboembolism

Treatments: Biological: blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT03309293

2017-A01591-52 (Registry Identifier)

2017-22

Details and patient eligibility

About

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.

Enrollment: 1,454 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women who had an episode of documented VTE (deep vein thrombosis and / or pulmonary embolism) under COC who consulted in a specialized counseling center.
• Women of age.
• Subject agreeing to participate in this research, having signed informed consent.

Exclusion criteria

• Absence of COC,
• No knowledge of the COC generation used by the patient,
• Undocumented MTEV Episode
• Absence of available sample (DNA),
• Refusal to participate in the study

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,454 participants in 2 patient groups

controls

Other group

Description:

biological samples bank

Treatment:

Biological: blood samples

cases

Experimental group

Treatment:

Biological: blood samples