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

Merkel Cell Carcinoma Clinical Trial

— SUMMERTIME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04705389
• Other study ID #: DR200079
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2021
• Est. completion date: September 2023

Study information

• Verified date: November 2020
• Source: University Hospital, Tours
• Contact: Mahtab SAMIMI, MD-PhD
• Phone: 02.47.47.46.25
• Email: mahtab.samimi[@]univ-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 2023
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Merkel Cell
• Merkel Cell Carcinoma

Intervention

Other:
• Samples
blood samples

Locations

Country	Name	City	State
Austria	Department of Dermatology, Medical University of Vienna	Vienna
Finland	University Hospital of Helsinki, Finland	Helsinki
France	Dermatology Dept, Hospital University of Tours	Tours
Germany	Translational Skin Cancer Research	Essen
Italy	National Tumour Institute "Fondazione G. Pascale" Unit of Melanoma - Cancer Immunotherapy and Innovative therapy	Naples
Netherlands	Academic Hospital of Maastricht	Maastricht
Romania	Department of Dermatology, Carol Davila University of Medicine and Pharmacy	Bucharest
Sweden	Skin Cancer and Surgery Center, Sahlgrenska University Hospital	Gothenburg
Turkey	Department of Dermatology, Baskent University Faculty of Medicine	Ankara
United Kingdom	Queen Elizabeth Hospital	Birmingham

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Tours	European Academy of Dermatology and Venerology

Countries where clinical trial is conducted

Austria,  Finland,  France,  Germany,  Italy,  Netherlands,  Romania,  Sweden,  Turkey,  United Kingdom, 

References & Publications (4)

Fan K, Ritter C, Nghiem P, Blom A, Verhaegen ME, Dlugosz A, Ødum N, Woetmann A, Tothill RW, Hicks RJ, Sand M, Schrama D, Schadendorf D, Ugurel S, Becker JC. Circulating Cell-Free miR-375 as Surrogate Marker of Tumor Burden in Merkel Cell Carcinoma. Clin Cancer Res. 2018 Dec 1;24(23):5873-5882. doi: 10.1158/1078-0432.CCR-18-1184. Epub 2018 Jul 30. — View Citation

Kervarrec T, Tallet A, Miquelestorena-Standley E, Houben R, Schrama D, Gambichler T, Berthon P, Le Corre Y, Hainaut-Wierzbicka E, Aubin F, Bens G, Tabareau-Delalande F, Beneton N, Fromont G, Arbion F, Leteurtre E, Touzé A, Samimi M, Guyétant S. Diagnostic accuracy of a panel of immunohistochemical and molecular markers to distinguish Merkel cell carcinoma from other neuroendocrine carcinomas. Mod Pathol. 2019 Apr;32(4):499-510. doi: 10.1038/s41379-018-0155-y. Epub 2018 Oct 22. — View Citation

Paulson KG, Lewis CW, Redman MW, Simonson WT, Lisberg A, Ritter D, Morishima C, Hutchinson K, Mudgistratova L, Blom A, Iyer J, Moshiri AS, Tarabadkar ES, Carter JJ, Bhatia S, Kawasumi M, Galloway DA, Wener MH, Nghiem P. Viral oncoprotein antibodies as a marker for recurrence of Merkel cell carcinoma: A prospective validation study. Cancer. 2017 Apr 15;123(8):1464-1474. doi: 10.1002/cncr.30475. Epub 2016 Dec 7. — View Citation

Samimi M, Molet L, Fleury M, Laude H, Carlotti A, Gardair C, Baudin M, Gouguet L, Maubec E, Avenel-Audran M, Esteve E, Wierzbicka-Hainaut E, Beneton N, Aubin F, Rozenberg F, Dupin N, Avril MF, Lorette G, Guyetant S, Coursaget P, Touzé A. Prognostic value of antibodies to Merkel cell polyomavirus T antigens and VP1 protein in patients with Merkel cell carcinoma. Br J Dermatol. 2016 Apr;174(4):813-22. doi: 10.1111/bjd.14313. Epub 2016 Feb 3. — View Citation

Outcome

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