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Clinical Trial Finder

Search Results

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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04705389
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Tours
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Mahtab SAMIMI, MD-PhD
Principal Investigator Affiliation University Hospital, Tours
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Austria, Finland, France, Germany, Italy, Netherlands, Romania, Sweden, Turkey, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Merkel Cell Carcinoma
Arms & Interventions

Arms

Other: Case group

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

Interventions

Other: - Samples

blood samples

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Vienna, Austria

Status

Address

Department of Dermatology, Medical University of Vienna

Vienna, ,

Site Contact

Robert Loewe, MD

[email protected]

02.47.47.46.25

University Hospital of Helsinki, Finland, Helsinki, Finland

Status

Address

University Hospital of Helsinki, Finland

Helsinki, , 00100

Site Contact

Helka Sahi, MD PhD

[email protected]

02.47.47.46.25

Tours, France

Status

Address

Dermatology Dept, Hospital University of Tours

Tours, , 37044

Site Contact

Mahtab SAMIMI, MD-PhD

[email protected]

02.47.47.46.25

Translational Skin Cancer Research, Essen, Germany

Status

Address

Translational Skin Cancer Research

Essen, , 45141

Site Contact

Jurgen Becker, MD PhD

[email protected]

02.47.47.46.25

Naples, Italy

Status

Address

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

Naples, , 80131

Site Contact

Paolo Ascierto, MD

[email protected]

02.47.47.46.25

Academic Hospital of Maastricht, Maastricht, Netherlands

Status

Address

Academic Hospital of Maastricht

Maastricht, ,

Site Contact

Nicole KELLENERS-SMITH, MD PhD

[email protected]

02.47.47.46.25

Bucharest, Romania

Status

Address

Department of Dermatology, Carol Davila University of Medicine and Pharmacy

Bucharest, , 050474

Site Contact

Ana Maria Forsea, MD PhD

[email protected]

02.47.47.46.25

Gothenburg, Sweden

Status

Address

Skin Cancer and Surgery Center, Sahlgrenska University Hospital

Gothenburg, ,

Site Contact

John Paoli, MD PhD

[email protected]

02.47.47.46.25

Ankara, Turkey

Status

Address

Department of Dermatology, Başkent University Faculty of Medicine

Ankara, ,

Site Contact

Deniz SECKIN, MD

[email protected]

02.47.47.46.25

Queen Elizabeth Hospital, Birmingham, United Kingdom

Status

Address

Queen Elizabeth Hospital

Birmingham, ,

Site Contact

Agustin Martin-Clavijo, MD

[email protected]

02.47.47.46.25

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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