The improved fibrin generation test, and other biomarkers are predictive for venous thromboembolism in cancer patients
ID
Bron
Verkorte titel
Aandoening
Venous thromboembolism, arterial thromboembolism
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The purpose of current study is to evaluate the predictive performance of the improved FGT for the development of VTE in pancreatic cancer patients. The primary outcome is
VTE occurring within 6 months from enrolment, including any symptomatic proximal and distal DVT of the upper or lower limbs, any non-fatal symptomatic or incidental segmental of more proximal PE, VTE-related deaths (fatal PE or unexplained death), as well as all other sites of VTE (distal upper & lower DVT, cerebral vein, splenic vein, renal vein, gonadal vein). Catheter related venous thromboembolism will not be considered as the primary outcome. The diagnosis needs to be confirmed by an independent radiologist by means of ultrasonography or computed tomography. No routine radiologic imaging will be performed for this study.
Achtergrond van het onderzoek
Rationale: Venous thromboembolism is a relevant complication in cancer patients as it is associated with substantial morbidity, can lead to cancer treatment interruption, and is the second cause of death after cancer progression itself. Patients with pancreatic cancer are at very high risk of developing venous thromboembolism, which is thought to be due to the release of extracellular vesicles that carry tissue factor by tumor cells. The fibrin generation test aims to measure the coagulant activity associated with these tissue factor carrying extracellular vesicles. The test was recently improved and could be a valuable tool for predicting venous thromboembolism.
Objective: The main objective is to assess the reproducibility of the improved fibrin generation test and its value in predicting venous thromboembolism in pancreatic cancer patients. Secondary objectives are to assess the predictive value of several other potentially predictive (bio)markers.
Doel van het onderzoek
The improved fibrin generation test, and other biomarkers are predictive for venous thromboembolism in cancer patients
Onderzoeksopzet
Baseline and 6 months follow-up
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Adenocarcinoma of the pancreas confirmed by histology or radiologic imaging.
• Planned for a new course of chemotherapy
• 18 years of age or older
• Fully capable of making health related decisions and written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Adjuvant chemotherapy.
• Current prophylactic or therapeutic anticoagulant therapy (unfractionated heparin, low molecular weight heparin, vitamin K antagonists, or direct oral anticoagulants).
• Venous thromboembolism < 3 months prior to chemotherapy.
• Surgery within the last month
• Start of chemotherapy before enrolment
• The presence of an inferior vena cava filter
• Currently pregnant
• Life expectancy of <3 months
• Bacterial or viral infection in the previous 2 weeks, defined by fever and clinical symptoms.
• Chemotherapy in the last month
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7660 |
| CCMO | NL66531.018.18 |
| OMON | NL-OMON52393 |