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

NCT ID: NCT04705389

Last Updated: 2021-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2023-09-30

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

Conditions

Merkel Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Case group

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

Group Type: OTHER

Samples

Intervention Type: OTHER

blood samples

Interventions

Samples

blood samples

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Academy of Dermatology and Venerology

UNKNOWN

Sponsor Role: collaborator

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahtab SAMIMI, MD-PhD

Role: STUDY_DIRECTOR

University Hospital, Tours

Locations

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

Countries

Austria; Finland; France; Germany; Italy; Netherlands; Romania; Sweden; Turkey (Türkiye); United Kingdom

Central Contacts

Mahtab SAMIMI, MD-PhD

Role: CONTACT

mahtab.samimi@univ-tours.fr

02.47.47.46.25 ext. +33

Facility Contacts

Robert Loewe, MD

Role: primary

robert.loewe@meduniwien.ac.at

Helka Sahi, MD PhD

Role: primary

helka.sahi@hus.fi

Mahtab SAMIMI, MD-PhD

Role: primary

mahtab.samimi@univ-tours.fr

Jurgen Becker, MD PhD

Role: primary

j.becker@dkfz-heidelberg.de

Paolo Ascierto, MD

Role: primary

paolo.ascierto@gmail.com

Nicole KELLENERS-SMITH, MD PhD

Role: primary

n.kelleners.smeets@mumc.nl

Ana Maria Forsea, MD PhD

Role: primary

aforsea@yahoo.com

John Paoli, MD PhD

Role: primary

john.paoli@vgregion.se

Deniz SECKIN, MD

Role: primary

denizseckin50@gmail.com

Agustin Martin-Clavijo, MD

Role: primary

agustin.martin-clavijo@uhb.nhs.uk

References

Fan K, Ritter C, Nghiem P, Blom A, Verhaegen ME, Dlugosz A, Odum 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.

Reference Type: BACKGROUND

PMID: 30061360 (View on PubMed)

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, Touze A, Samimi M, Guyetant 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.

Reference Type: BACKGROUND

PMID: 30349028 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 27925665 (View on PubMed)

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, Touze 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.

Reference Type: BACKGROUND

PMID: 26600395 (View on PubMed)

Other Identifiers

DR200079

Identifier Type: -

Identifier Source: org_study_id