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

NCT03309293 | Completed

• 2 other identifiers: 2017-222017-A01591-52
• Study Type: interventional
• Target: 1,454
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Build a predictive score for VTE in women using COC

  this score is based on clinical and biological factors

  42 months

Study Arms (2)

controls

OTHER

biological samples bank

Biological: blood samples

cases

EXPERIMENTAL

Biological: blood samples

Interventions

blood samples BIOLOGICAL

blood samples

cases; controls

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• jean-olivier ARNAUD

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 13, 2017
• Study Start: January 18, 2017
• Primary Completion: November 9, 2023
• Study Completion: November 9, 2023
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

FR (1)