EICHORCondition: Merkel Cell Carcinoma · Sponsor: University Hospital, Tours
Merkel cell carcinoma (MCC) is a rare aggressive skin carcinoma. Approximately 80% of MCC are related to the Merkel Cell Polyomavirus (MCPyV). Although rates of relapse are high, the follow-up strategy lacks consensus. Patients are usually assessed clinically every 3 to 6 months for the first 2-3 years, and every 6 to 12 months thereafter. In the European guidelines, patients with early stages are monitored with clinical examination and ultrasonography of lymph nodes, while whole-body imaging is optional in patients with stage III disease, on a yearly basis for 5 years. Such strategy may prevent the diagnosis of infra-clinical recurrences, whereas patients could still be treated with surgery or radiation therapy. Until 2017, patients with advanced disease were treated with chemotherapies, with no long-term benefit. Immunotherapies with PD-1/PD-L1 inhibitors currently allow durable responses in 50% of such patients. This major change in the management of MCC patients argues for a follow-up strategy that would allow early diagnosis of infra-clinical metastases, when tumoral burden is still low. Given that all patients cannot be monitored by systematic regular imaging, additional non-invasive tools are needed. Blood-based biomarkers as a surrogate of tumor burden are advantageous as they can be repeated over time, providing guidance on when imaging is necessary. The study aims to assess two blood biomarkers, MCPyV T-Ag antibodies and cell-free miR-375, in a prospective fashion f…
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| Department of Dermatology, Medical University of Vienna | Vienna, Austria | — |
| University Hospital of Helsinki, Finland | Helsinki, Finland | — |
| Dermatology Dept, Hospital University of Tours | Tours, France | — |
| Translational Skin Cancer Research | Essen, Germany | — |
| National Tumour Institute "Fondazione G. Pascale" Unit of Melanoma - Cancer Immunotherapy and Innovative therapy | Naples, Italy | — |
| Academic Hospital of Maastricht | Maastricht, Netherlands | — |
| Department of Dermatology, Carol Davila University of Medicine and Pharmacy | Bucharest, Romania | — |
| Skin Cancer and Surgery Center, Sahlgrenska University Hospital | Gothenburg, Sweden | — |
| Department of Dermatology, Başkent University Faculty of Medicine | Ankara, Turkey (Türkiye) | — |
| Queen Elizabeth Hospital | Birmingham, United Kingdom | — |
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Source record: clinicaltrials.gov/study/NCT04705389