An observational study in Testicular Cancer and Cardiovascular Diseases, sponsored by NHS Greater Glasgow and Clyde. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-11-25.
Sponsored by NHS Greater Glasgow and Clyde · Observational
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.
191 studies on the registry are indexed under Testicular Neoplasms; 53 are open to participants now.
This study's enrollment of 36 is below the median of 133 across 62 observational studies indexed under Testicular Neoplasms.
Browse Testicular Neoplasms studies →NHS Greater Glasgow and Clyde is the lead sponsor of 220 studies on the registry; 39 are open to participants now.
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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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Exclusion Criteria:
Change in flow-mediated dilatation post cisplatin based chemotherapy
Maximum change in flow-mediated dilatation post cisplatin based chemotherapy
Time frame: 9 months
Percentage change in circulating platelet monocyte aggregates post cisplatin based chemotherapy
Maximum change in percentage circulating platelet monocyte aggregates post cisplatin based chemotherapy
Time frame: 9 months
Plan to share: Undecided
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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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NHS Greater Glasgow and Clyde →