Predicting blood clot risks in cancer patients
Thrombin Generation and Prediction of Thromboembolic Events in Oncology Patients at Risk
NA · Institut Cancerologie de l'Ouest · NCT06051214
This study is testing if measuring certain blood factors can help predict blood clot risks in cancer patients who are at high risk for complications during treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Cancerologie de l'Ouest (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Saint-Herblain) |
| Trial ID | NCT06051214 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate thrombin generation and its role in predicting thromboembolic events in patients with solid tumors at high risk for thrombosis. Biological blood samples will be collected monthly for a year following the initiation of systemic treatment to analyze coagulation factors. The study focuses on understanding the hypercoagulable state associated with cancer and how it contributes to venous thromboembolism (VTE), a significant complication in these patients. By identifying patients at risk, the study seeks to improve management and outcomes for cancer patients undergoing treatment.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with solid cancers such as lung, pancreatic, gastric, or glioblastoma that are at high risk for thrombosis and have not yet received systemic treatment.
Not a fit: Patients who have experienced a venous thromboembolism in the past year or are currently on anticoagulant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prediction and prevention of thromboembolic events in cancer patients, potentially improving survival rates.
How similar studies have performed: Other studies have shown success in identifying thromboembolic risks in cancer patients, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Saint-Herblain
- Institut de Cancerologie de L'Ouest — Saint-Herblain, France (RECRUITING)
Study contacts
- Principal investigator: Judith RAIMBOURG, MD — INSTITUT DE CANCEROLOGIE DE L'OUEST
- Study coordinator: Armelle LEFRANCOIS
- Email: armelle.lefrançois@ico.unicancer.fr
- Phone: +33240679727
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Solid Carcinoma