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

May 17, 2021 updated by: University Hospital, Tours
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria
        • Department of Dermatology, Medical University of Vienna
        • Contact:
        • Principal Investigator:
          • Robert Loewe
  • Finland
      • Helsinki, Finland, 00100
        • University Hospital of Helsinki, Finland
        • Contact:
        • Principal Investigator:
          • Helka Sahi
  • France
      • Tours, France, 37044
        • Dermatology Dept, Hospital University of Tours
        • Contact:
        • Principal Investigator:
          • Mahtab SAMIMI, MD-PhD
  • Germany
      • Essen, Germany, 45141
        • Translational Skin Cancer Research
        • Contact:
        • Principal Investigator:
          • Jurgen Becker
  • Italy
      • Naples, Italy, 80131
        • National Tumour Institute "Fondazione G. Pascale" Unit of Melanoma - Cancer Immunotherapy and Innovative therapy
  • Netherlands
      • Maastricht, Netherlands
        • Academic Hospital of Maastricht
        • Contact:
        • Principal Investigator:
          • Nicole KELLENERS-SMITH
  • Romania
      • Bucharest, Romania, 050474
        • Department of Dermatology, Carol Davila University of Medicine and Pharmacy
        • Contact:
        • Principal Investigator:
          • Ana Maria Forsea
  • Sweden
      • Gothenburg, Sweden
        • Skin Cancer and Surgery Center, Sahlgrenska University Hospital
        • Contact:
        • Principal Investigator:
          • John Paoli
  • Turkey
      • Ankara, Turkey
        • Department of Dermatology, Başkent University Faculty of Medicine
        • Contact:
        • Principal Investigator:
          • Deniz SECKIN
  • United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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).
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Collaborators

European Academy of Dermatology and Venerology

Investigators

  • Study Director: Mahtab SAMIMI, MD-PhD, University Hospital, Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2021

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

September 1, 2023

Study Registration Dates

First Submitted

January 8, 2021

First Submitted That Met QC Criteria

January 8, 2021

First Posted (ACTUAL)

January 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR200079

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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