An observational study in Testicular Cancer, sponsored by University Medical Center Groningen. Completed at 5 sites in 3 countries. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-05-17.
Sponsored by University Medical Center Groningen · Observational
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.
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.
189 studies on the registry are indexed under Testicular Neoplasms; 53 are open to participants now.
This study's enrollment of 101 is below the median of 145 across 61 observational studies indexed under Testicular Neoplasms.
Browse Testicular Neoplasms studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
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Newly diagnosed testicular cancer patients before start of chemotherapy.
Exclusion Criteria:
Development of arterial cardiovascular events
Primary outcome is development of arterial cardiovascular events within the first year after start of chemotherapy. Events taken into account are: myocardial infarction (WHO ICD-10 I20-I25), ischemic cerebrovascular accidents (WHO ICD-10 I63-I66 and G45) or infarction in other specific organ systems (WHO ICD-10 K76.3, K55, D73.5, M62.2, N28.0)
Time frame: first year after start of chemotherapy
Overall survival
Time frame: first year after start of chemotherapy
Response to testicular cancer treatment (no evidence of disease / relapse / no response to treatment)
Time frame: first year after start of chemotherapy
Development of venous thromboembolic events (VTE) (WHO ICD-10 I26, I80-82)
Time frame: first year after start of chemotherapy
Plan to share: No
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University Medical Center Groningen