SerUM Markers in MERkel Cell Carcinoma Patients: a Longitudinal moniTorIng Study for optiMization of European Guidelines

Not Applicable

• Conditions: Merkel Cell Carcinoma

• Registration Number: NCT04705389
• Lead Sponsor: University Hospital, Tours

Brief Summary

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 from baseline diagnosis, in a cohort of 150 European MCC patients

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-12
• Last Update Submitted: 2021-05-17
• Last Update Posted: 2021-05-18
• Study Start: 2021-09
• Primary Completion: 2021-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients with a " de novo " diagnosis of MCC, confirmed on histological criteria (neuroendocrine morphology, CK20 staining and/or neuroendocrine and/or SATB2 staining, exclusion of differential diagnosis)
• ≥ 18 years of age
• Written informed consent obtained from the participant

Exclusion Criteria

• Patients following any measures of legal presentation
• Pregnancy or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess the diagnostic performances of two blood biomarkers (T-antigen antibodies and miR375) in detecting disease recurrence during follow up of patients with Merkel Cell Carcinoma	12 months	Diagnostic performances (specificity, sensitivity, predictive values) of each biomarker will be assessed at the end of follow up, in relation with patients' outcomes (remission and recurrence).

Secondary Outcome Measures

Name	Time	Method
To assess if these two blood biomarkers (T-antigen antibodies and miR375) assessed at baseline are associated with prognosis and response to treatments.	12 months	Cox regression analysis will be performed to evaluate the clinical and biological factors associated with recurrence, death of disease, response to treatments.

Trial Locations

Locations (10)

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

Queen Elizabeth Hospital; 🇬🇧 Birmingham, United Kingdom