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

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Carcinoma
• Intervention / Treatment: Biological: thrombogram

Detailed Description

Biological blood samples will be taken specifically for research purposes. As far as possible and depending on the patient's schedule, a sample will be taken every month (during a consultation and/or a course of chemotherapy) and for the 12 months following the initiation of systemic treatment

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Armelle LEFRANCOIS; Phone Number: +33240679727; Email: armelle.lefrançois@ico.unicancer.fr
• Study Contact Backup: Name: LAETITIA HIMPE; Phone Number: +33240679747; Email: laetitia.himpe@ico.unicancer.fr

Study Locations

• France
  • Saint-Herblain, France, 44805
    • Recruiting
    • Institut de Cancérologie de l'Ouest
    • Contact: Judith RAIMBOURG; Email: Judith.raimbourg@ico.unicancer.fr
    • Contact: Armelle LEFRANCOIS; Email: armelle.lefrancois@ico.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient aged > 18 years,
2. Patient with a solid cancer at high risk of thrombosis, whether metastatic or not (lung, pancreatic, gastric or glioblastoma cancers)1,
3. Patients who have not received any systemic treatment for their cancer,
4. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thrombogram; Blood sampling every month for 12 months	Biological: thrombogram; blood sampling every month for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe kinetic evolution of thrombogram after different chemotherapies	Area Under the Curve/ Endogenous Thrombin Potential(ETP) (nM.min)	Every 3 months for 12 months
Describe kinetic evolution of thrombogram in metastatic disease	Analysis of Area Under the Curve/ Endogenous Thrombin Potential(ETP) (nM.min) will be done before and after metastatic progression, or at each progression for patients with immediate metastatic disease.	Every 3 months for 12 months
Identify specific patterns of thrombogram evolution over time	Homogeneous patient trajectories will be identified by evolution of Area Under the Curve/ Endogenous Thrombin Potential(ETP) (nM.min)	Every 3 months for 12 months

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Collaborators: Diagnostica Stago
• Investigators: Principal Investigator: Judith RAIMBOURG, MD, Institut de Cancérologie de l'Ouest

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism
• Other Study ID Numbers: ICO-2022-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No