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

Venous Thromboembolism Clinical Trial

— PILGRIM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03309293
• Other study ID #: 2017-22
• Secondary ID: 2017-A01591-52
• Status: Not yet recruiting
• Phase: N/A
• First received: October 5, 2017
• Last updated: October 12, 2017
• Start date: October 2017
• Est. completion date: February 2022

Study information

• Verified date: October 2017
• Source: Assistance Publique Hopitaux De Marseille
• Contact: pierre SUCHON
• Phone: 04 91 38 60 48
• Email: pierre.suchon[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1501
• Est. completion date: February 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Biological:
• blood samples
blood samples

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Build a predictive score for VTE in women using COC	this score is based on clinical and biological factors	42 months