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| Name | Class |
|---|---|
| University of Glasgow | OTHER |
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incidence is increasing1,2. Whilst the prognosis is very good with the vast majority of patients cured with orchidectomy alone, those with high risk stage one non seminomatous germ cell cancer (NSCGT) or metastatic disease (NSCGT or seminoma) are treated by surgery followed by chemotherapy. Platinum based chemotherapy is associated with long-term cardiovascular sequelae.
Endothelial dysfunction is a key component of early atherogenesis and the later stages of obstructive atherosclerosis, plaque rupture and thrombus formation. Whilst endothelial toxic effects of BEP chemotherapy appear to be central in the pathophysiology of associated complications, abnormalities in endothelial function as assessed by measures of brachial artery flow-mediated dilatation (FMD) have not demonstrated a consistent effect over time. When assessed within ten weeks of platinum-based chemotherapy9, no change in FMD was observed whilst marked decreases are seen immediately following treatment11 and also one year following treatment12. Therefore, the time-course of endothelial vasomotor impairment remains incompletely defined in a single prospective cohort.
There remains an unmet need to identify a preventive treatment for patients with testicular cancer treated with platinum based chemotherapy to diminish the substantial risk of subsequent cardiovascular events. A future randomised trial of statin therapy in these patients is under consideration and results from this pilot study will inform its design.
Before moving towards interventional studies the proposed pilot study will enable a better understanding of the nature, time-course and dose-dependent effects of the mechanisms contributing to increased cardiovascular risk.
Single-centre, prospective pilot study assessing the cardiovascular effects of treatment with orchidectomy or orchidectomy plus cisplatin based chemotherapy for testicular cancer.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in flow-mediated dilatation post cisplatin based chemotherapy | Maximum change in flow-mediated dilatation post cisplatin based chemotherapy | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in circulating platelet monocyte aggregates post cisplatin based chemotherapy | Maximum change in percentage circulating platelet monocyte aggregates post cisplatin based chemotherapy | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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Orchidectomy alone or Orchidectomy plus 1-2 cycles adjuvant cisplatin based chemotherapy or Orchidectomy plus 3-4 cycles cisplatin based chemotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Ninian Lang, MBChB PhD | QEUH, NHS Greater Glasgow and Clyde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beatson West of Scotland Cancer Centre | Glasgow | G51 4TF | United Kingdom |
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| ID | Term |
|---|---|
| D013736 | Testicular Neoplasms |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005834 | Genital Neoplasms, Male |
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biological blood samples will be retained without DNA
| D014565 |
| Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |