Last reviewed · How we verify
NCT03309293: PILGRIM
Construction and External Validation of a Predictive Clinico-biological Score of the Risk of Venous Thrombosis in Women Under Combined Oral Contraceptives
NA trial testing blood samples in Venous Thromboembolism in 1,454 participants. Completed in 9 November 2023.
9 November 2023
Quick facts
| Lead sponsor | Assistance Publique Hopitaux De Marseille |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 1,454 |
| Start date | 18 January 2017 |
| Primary completion | 9 November 2023 |
| Estimated completion | 9 November 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- blood samples — full drug profile →
Conditions studied
- Venous Thromboembolism — all drugs for Venous Thromboembolism →
Sponsor
Assistance Publique Hopitaux De Marseille — full company profile →
Who can join
18 and older, female only, with Venous Thromboembolism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03309293
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of blood samples
Trials testing the same drug.
- NCT07070102 — Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children · not yet recruiting
- NCT06252415 — Evaluation of Rapid First-line Genome Sequencing for Prenatal Diagnosis of Congenital Malformations in Comparison With C · completed
- NCT05472883 — Identification of Human Biomarkers Predictive of Diabetes Remission in Type 2 Diabetes Patient (BARIAKINES) · NA · recruiting
- NCT05472519 — Immunopathology of Loeys-Dietz Syndrome · NA · completed
- NCT07069296 — Impact of Gestational Diabetes on Childhood Obesity · NA · completed
Other recruiting trials for Venous Thromboembolism
Currently open trials in the same condition.
- NCT07399977 — Using a Blood Test and Software Tool to Guide Treatment for Venous Thromboembolism · NA · recruiting
- NCT06861088 — The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer · Phase 3 · recruiting
- NCT07140523 — A Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing TKA · Phase 2 · recruiting
- NCT04211181 — CHIPs-VTE Study in Hospitalized Patients to Prevent Hospital-Acquired Venous Thromboembolism · NA · recruiting
- NCT06440694 — Colchicine to Quench the Inflammatory Response After Deep Vein Thrombosis (The Conquer-DVT Pilot Trial) · Phase 3 · recruiting
Other Assistance Publique Hopitaux De Marseille trials
Trials by the same sponsor.
- NCT07521644 — Dysbiosis of Methanogenic Archaea and Nanoarchaea in the Oral Microbiome · NA · not yet recruiting
- NCT07357025 — Resting-State fMRI Study of Functional Connectivity After Gamma Knife Radiosurgery in Trigeminal Neuralgia · NA · not yet recruiting
- NCT07356661 — Evaluation of the Efficacy of Neurofeedback Technique Based on EEG Desynchronization in Epileptic Patients · NA · not yet recruiting
- NCT07399327 — Biomarkers of Response to SEEG Thermocoagulation · NA · not yet recruiting
- NCT06999499 — Development of an Aid to Melanoma Detection Using Artificial Intelligence Algorithms Based on Images From the VECTRA 3D · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03309293 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille
- Last refreshed: 27 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03309293.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing