Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06051214

Thrombin Generation and Prediction of Thromboembolic Events in Oncology Patients at Risk

Led by Institut Cancerologie de l'Ouest · Updated on 2026-02-17

200

Participants Needed

1

Research Sites

259 weeks

Total Duration

On this page

Sponsors

I

Institut Cancerologie de l'Ouest

Lead Sponsor

D

Diagnostica Stago

Collaborating Sponsor

AI-Summary

What this Trial Is About

Coagulation is a complex system which, through the action of thrombin, leads to the formation of fibrin, which stabilises the platelet clot. Any disturbance in the balance between procoagulant and anticoagulant factors can tip the physiological process either towards a state of hypercoagulability leading to thrombosis or hypocoagulability responsible for bleeding. Due to a number of factors, cancer is associated with a state of hypercoagulability, leading to thrombosis. The incidence of venous thromboembolism (VTE) in cancer patients varies from 15 to 20% depending on the type of cancer, the stage of the disease and the associated treatments (ONCORIF data, November 2021). The risk of venous thromboembolism (VTE) is greatly increased in cancer patients (RR x 3 to 6) and doubled in the case of associated chemotherapy (1). VTE is a poor prognostic factor, occurs mainly in the first 6 months after diagnosis and is the second leading cause of death in cancer patients. At present, haemostasis tests performed in medical laboratories independently explore the different coagulation pathways but do not allow the overall haemostatic profile of a hyper- or hypocoagulable patient to be assess. Based on this knowledge base, the aim of our study will be to monitor thrombogram profiles during the management of patients with tumours at high risk of thromboembolism (lung, pancreas, stomach, glioblastoma) and to correlate these profiles with the risk of a thromboembolic event occurring in these patients. The aim of the project is to validate a simple predictive test (suitable for clinical use) for the risk of thromboembolism in these patients. These analyses will also make it possible to monitor the impact of chemotherapy on changes in the thrombin generation test in patients.

CONDITIONS

Official Title

Thrombin Generation and Prediction of Thromboembolic Events in Oncology Patients at Risk

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged > 18 years
  • Diagnosis of solid cancer with high risk of thrombosis (lung, pancreatic, gastric, or glioblastoma cancer)
  • No prior systemic treatment for cancer
  • Provided informed consent for data use and biological sample collection
Not Eligible

You will not qualify if you...

  • History of venous thromboembolism in the 12 months before cancer diagnosis
  • Current use of low molecular weight heparins, standard unfractionated heparins, or anti-vitamin K medications
  • Pregnant, breastfeeding, or likely to become pregnant
  • Under legal protection such as custody, guardianship, or court supervision
  • Unable to comply with medical monitoring due to geographic, social, or psychological reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Institut de Cancerologie de L'Ouest

Saint-Herblain, France, 44805

Actively Recruiting

Loading map...

Research Team

A

Armelle LEFRANCOIS

CONTACT

L

LAETITIA HIMPE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here