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

NCT04705389 | Unknown

• 1 other identifier: DR200079
• Study Type: interventional
• Target: 150
• Locations: 10 countries
• Sites: 10

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

Keywords

biomarker; monitoring; prognosis; merkel cell polyomavirus; miR375; T-antigen antibodies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Case group

OTHER

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

Other: Samples

Interventions

Samples OTHER

blood samples

Case group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age
• Written informed consent obtained from the participant

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Tours: lead
• European Academy of Dermatology and Venerology: collaborator

Study Sites (10)

Department of Dermatology, Medical University of Vienna

Vienna, Austria

Location

University Hospital of Helsinki, Finland

Helsinki, 00100, Finland

Location

Dermatology Dept, Hospital University of Tours

Tours, 37044, France

Location

Translational Skin Cancer Research

Essen, 45141, Germany

Location

National Tumour Institute "Fondazione G. Pascale" Unit of Melanoma - Cancer Immunotherapy and Innovative therapy

Naples, 80131, Italy

Location

Academic Hospital of Maastricht

Maastricht, Netherlands

Location

Department of Dermatology, Carol Davila University of Medicine and Pharmacy

Bucharest, 050474, Romania

Location

Skin Cancer and Surgery Center, Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Department of Dermatology, Başkent University Faculty of Medicine

Ankara, Turkey (Türkiye)

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 30061360 BACKGROUND

• 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.

  PMID: 30349028 BACKGROUND

• 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.

  PMID: 27925665 BACKGROUND

• 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.

  PMID: 26600395 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Merkel Cell

Interventions

Sampling Studies

Condition Hierarchy (Ancestors)

Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mahtab SAMIMI, MD-PhD

  University Hospital, Tours

  STUDY DIRECTOR

Central Study Contacts

Mahtab SAMIMI, MD-PhD

CONTACT

02.47.47.46.25; mahtab.samimi@univ-tours.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 12, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2023
• Last Updated: May 18, 2021

Record last verified: 2020-11

Locations

FI (1); IT (1); RO (1); GB (1); SE (1); FR (1); AU (1); DE (1); NL (1); TU (1)