VTE risk prediction might be improved by using the modified risk scores.
ID
Bron
Verkorte titel
Aandoening
Cancer-associated venous thromboembolism
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Venous thromboembolism in the 6 months following cancer diagnosis
Achtergrond van het onderzoek
Venous thromboembolism (VTE) is a common complication in patients with cancer, leading to increased mortality and morbidity, decreased quality of life and higher healthcare costs. Primary thromboprophylaxis with low molecular weight heparin (LMWH) has been shown to be efficacious in preventing VTE, reducing the risk with 46%. However, current international guidelines do not recommend routine prophylactic anticoagulant therapy in ambulatory cancer patients due to an unfavorable risk-benefit ratio. Risk stratification tools using clinical and laboratory variables have been developed to help predict which patients will develop cancer-associated VTE. However, external validation of these tools remain needed before clinical implementation can be justified. The main objective of this study is to evaluate and compare the performance several risk scores, including the Khorana, PROTECHT and CONKO and TIC-ONCO score. In addition, the additive value of other clinical risk factors and genetic mutations will be evaluated.
We aim to enroll all CPCT-02 study (clinicaltrials.gov identifier: NCT01855477) participants in a retrospective cohort study. Enrollment of at least thousand patients is intended in order to observe around 50-80 events to provide sufficient statistical power.
Doel van het onderzoek
VTE risk prediction might be improved by using the modified risk scores.
Onderzoeksopzet
6 months from entry time, 12 months from entry time, and longer follow-up periods.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Adult patients (age >18 years)
- Ambulatory setting
- Histologically or cytologically confirmed cancer
- Chemotherapy indicated within 3 months
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Desmoid tumors
- Pre-stages of cancer
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL8010 |
Ander register | The study has been declared not to be subject to the Medical Research Involving Human Subject Act (WMO). The study was approved by the Independent Review Board (IRB) in hospitals were this was required. : MEC-2018-1468 |