No registrations found.
ID
Source
Brief title
Health condition
Cancer-associated venous thromboembolism
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Venous thromboembolism in the 6 months following cancer diagnosis
Secondary outcome
- Venous thromboembolism in 12 months and longer follow-up periods after cancer diagnosis.
- Venous thromboembolism in the 6 months, 12 months and longer follow-up periods after reactivation of cancer.
- Arterial thromboembolism in 6 months, 12 months and longer follow-up periods after primary cancer diagnosis or reactivation of cancer.
- Mortality in 6 months, 12 months, and longer follow-up periods after primary cancer diagnosis.
Background summary
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.
Study objective
VTE risk prediction might be improved by using the modified risk scores.
Study design
6 months from entry time, 12 months from entry time, and longer follow-up periods.
Inclusion criteria
- Adult patients (age >18 years)
- Ambulatory setting
- Histologically or cytologically confirmed cancer
- Chemotherapy indicated within 3 months
Exclusion criteria
- Desmoid tumors
- Pre-stages of cancer
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8010 |
| Other | 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 |