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

Sponsor

University Hospital, Tours (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04705389

Collaborator

European Academy of Dermatology and Venerology (Other)

150

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Merkel Cell Carcinoma	Other: Samples	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Case group Intervention only includes additional blood sampling at baseline and during follow up (5 samplings).	Other: Samples blood samples

Arm

Intervention/Treatment

Other: Case group

Intervention only includes additional blood sampling at baseline and during follow up (5 samplings).

Other: Samples

blood samples

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Department of Dermatology, Medical University of Vienna	Vienna	Austria
2	University Hospital of Helsinki, Finland	Helsinki	Finland	00100
3	Dermatology Dept, Hospital University of Tours	Tours	France	37044
4	Translational Skin Cancer Research	Essen	Germany	45141
5	National Tumour Institute "Fondazione G. Pascale" Unit of Melanoma - Cancer Immunotherapy and Innovative therapy	Naples	Italy	80131
6	Academic Hospital of Maastricht	Maastricht	Netherlands
7	Department of Dermatology, Carol Davila University of Medicine and Pharmacy	Bucharest	Romania	050474
8	Skin Cancer and Surgery Center, Sahlgrenska University Hospital	Gothenburg	Sweden
9	Department of Dermatology, Başkent University Faculty of Medicine	Ankara	Turkey
10	Queen Elizabeth Hospital	Birmingham	United Kingdom