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CompletedNCT03309293PILGRIMUpdated Jun 27, 2025

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

An interventional study of blood samples in Venous Thromboembolism, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-27.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,454
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Venous Thromboembolism
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,454 participants (actual)

Study arms

  • Other
    controls

    biological samples bank

    Biological: blood samples

  • Experimental
    cases

    Biological: blood samples

Interventions

  • Biologicalblood samples

    blood samples

05

What researchers measure

Primary outcomes

  1. Build a predictive score for VTE in women using COC

    this score is based on clinical and biological factors

    Time frame: 42 months

06

Study locations

1 site
  • Assistance Publique Hopitaux de Marseille
    Marseille, 13354, France
07

Registry details

Key details

Study ID
NCT03309293
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Oct 13, 2017
Start date
Jan 18, 2017
Primary completion
Nov 9, 2023
Completion
Nov 9, 2023
Last update
Jun 27, 2025

Study contacts

jean-olivier ARNAUD
study director · Assistance Publique Hopitaux De Marseille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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