Vascular Fingerprint Validation Study

  • STATUS
    Recruiting
  • End date
    May 29, 2023
  • participants needed
    178
  • sponsor
    University Medical Center Groningen
Updated on 29 May 2022

Summary

The vascular fingerprint is a simple selection tool to identify testicular cancer patients with a high risk of arterial cardiovascular events during and in the first year after cisplatin chemotherapy. Eventually, this selection method allows a relative small randomized intervention study with i.e. LMWH during chemotherapy to prove the effectiveness and safety in lowering the chance of an arterial cardiovascular event.

Description

Since the introduction of cisplatin in the late seventies (1), the prognosis of metastatic testicular cancer patients has dramatically improved, with long-term survival rates of 80-90% (2). However, cure rates are compromised by the increased risk of cardiovascular events (3-5). Approximately 1-5% of the patients with metastatic testicular cancer develop arterial cardiovascular events during or shortly after cisplatin- and bleomycin containing chemotherapy (3-7). Arterial cardiovascular events include ischemic stroke and myocardial infarction. These arterial events are a source of serious treatment-induced morbidity and mortality as recently clearly confirmed by Fung (8). No established standard prophylaxis is available. There is an unmet need to have the possibility to identify high risk patients before start of chemotherapy in whom prophylactic anti-coagulant treatment may prevent events (9). An identification tool could maximize the benefit of an intervention without introducing too much unnecessary harm: preventive interventions also carry risk.

Recent data from the investigators' cancer center showed that before chemotherapy 22% of the metastatic cancer patients had ≥3 of the following 5 traditional cardiovascular risk factors present (high risk vascular fingerprint, figure 1): overweight, smoking, hypertension, dyslipidemia and impaired blood glucose. These patients had an increased risk to develop arterial events during or early after chemotherapy: 19% of the patients with a high risk vascular fingerprint developed an arterial cardiovascular event whereas only 2% of the patients with ≤2 risk factors developed an event . The vascular fingerprint seems an easy method to identify which metastatic testicular cancer patients are at a high risk for early arterial events and who may benefit from prophylaxis with for example low molecular weight heparins (LMWHs). To be used in the clinic these data need to be confirmed in an independent cohort.

Details
Condition Testicular Cancer
Clinical Study IdentifierNCT02573584
SponsorUniversity Medical Center Groningen
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of metastatic TC and an indication to start with first-line cisplatin-based chemotherapy for metastatic TC
Classified into IGCCCG good or intermediate prognosis group
Younger than 50 years of age at start of chemotherapy
Signed informed consent

Exclusion Criteria

History of previous cardiovascular disease
Retroperitoneal mass > 5 cm
Indication for anticoagulant therapy at start of chemotherapy
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