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

NCT06051214 | Recruiting

• 1 other identifier: ICO-2022-19
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Solid Carcinoma

Outcome Measures

Primary Outcomes (1)

• To assess whether changes in thrombogram values are predictive of thromboembolic events in patients with solid cancers in the 12 months following initiation of their systemic treatment.

  Venous thromboembolism (VTE)-free survival.

  12 months

Secondary Outcomes (3)

• Describe kinetic evolution of thrombogram after different chemotherapies

  Every 3 months for 12 months

• Describe kinetic evolution of thrombogram in metastatic disease

  Every 3 months for 12 months

• Identify specific patterns of thrombogram evolution over time

  Every 3 months for 12 months

Study Arms (1)

Thrombogram

EXPERIMENTAL

Blood sampling every month for 12 months

Biological: thrombogram

Interventions

thrombogram BIOLOGICAL

blood sampling every month for 12 months

Thrombogram

Eligibility Criteria

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

You may qualify if:

• Patient aged \> 18 years,
• Patient with a solid cancer at high risk of thrombosis, whether metastatic or not (lung, pancreatic, gastric or glioblastoma cancers)1,
• Patients who have not received any systemic treatment for their cancer,
• An informed patient who does not object to the use of data for research purposes and who has consented to the collection, use and storage of biological samples.

You may not qualify if:

• Patient who has had a VTE in the 12 months preceding the diagnosis of cancer,
• Patient on low molecular weight heparins, standard unfractionated heparins and anti-vitamin K2,
• Women who are pregnant, likely to become pregnant or who are breast-feeding,
• Persons deprived of their liberty, under court protection, under curators or under the authority of a guardian,
• Unable to undergo medical monitoring of the trial for geographical, social or psychological reasons.

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead
• Diagnostica Stago: collaborator

Study Sites (1)

Institut de Cancerologie de L'Ouest

Saint-Herblain, 44805, France

RECRUITING

Study Officials

• Judith RAIMBOURG, MD

  INSTITUT DE CANCEROLOGIE DE L'OUEST

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armelle LEFRANCOIS

CONTACT

+33240679727; armelle.lefrançois@ico.unicancer.fr

LAETITIA HIMPE

CONTACT

+33240679747; laetitia.himpe@ico.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 22, 2023
• Study Start: September 12, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)