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

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ClinicalTrials.gov Identifier: NCT03309293
Recruitment Status : Not yet recruiting
First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.


Condition or disease Intervention/treatment Phase
Venous Thromboembolism Biological: blood samples Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1501 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Construction and External Validation of a Predictive Clinico-biological Score of the Risk of Venous Thrombosis in Women Under Combined Oral Contraceptives
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
controls
biological samples bank
Biological: blood samples
blood samples

Experimental: cases Biological: blood samples
blood samples




Primary Outcome Measures :
  1. Build a predictive score for VTE in women using COC [ Time Frame: 42 months ]
    this score is based on clinical and biological factors



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309293


Contacts
Contact: pierre SUCHON 04 91 38 60 48 pierre.suchon@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Not yet recruiting
Marseille, France, 13354
Contact: jean-oilivier arnaud    04 91 38 27 47    drci@ap-hm.fr   
Principal Investigator: PIERRE SUCHON         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: jean-olivier ARNAUD Assistance Publique Hopitaux De Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03309293     History of Changes
Other Study ID Numbers: 2017-22
2017-A01591-52 ( Registry Identifier: n°IDRCB )
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Thrombosis
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female