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

NCT ID: NCT03309293

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1454 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-18
• Study Completion Date: 2023-11-09

Brief Summary

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.

Conditions

Venous Thromboembolism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

controls

biological samples bank

Group Type: OTHER

blood samples

Intervention Type: BIOLOGICAL

blood samples

cases

Group Type: EXPERIMENTAL

blood samples

Intervention Type: BIOLOGICAL

blood samples

Interventions

blood samples

blood samples

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

jean-olivier ARNAUD

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2017-A01591-52

Identifier Type: REGISTRY

Identifier Source: secondary_id

2017-22

Identifier Type: -

Identifier Source: org_study_id