Active not recruitingNAINTERVENTIONAL

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

This study is investigating new blood tests for a rare but aggressive form of skin cancer called Merkel cell carcinoma. We know this cancer can often return, but current ways of checking for this aren't always perfect. The study wants to find out if two specific blood tests – looking for Merkel Cell Polyomavirus (MCPyV) T-Ag antibodies and cell-free miR-375 – can help doctors detect the cancer coming back sooner. This could mean patients get treatment earlier, when it's more likely to be effective. The goal is to see if these blood tests can improve the current guidelines for monitoring patients across Europe.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospital, Tours

Enrolment target

Start

05 Dec 2022

Estimated completion

01 Dec 2026

Merkel Cell Carcinoma

What is this study about?

Merkel cell carcinoma is a rare type of skin cancer that can be quite aggressive. Doctors want to make sure they are giving patients the best care after their diagnosis, especially because the cancer can sometimes come back. Regularly checking for the cancer returning is very important, but the current methods, like scans and physical exams, might not always catch everything early enough.

Recently, there have been big improvements in treating advanced Merkel cell carcinoma, especially with new medicines that boost the body's own immune system. This means that finding the cancer returning at its earliest stage, when it might still be very small, is now more important than ever. If doctors can spot it early, treatments like surgery or radiotherapy can be more effective.

This study is looking into whether new blood tests can help. While regular body scans can be useful, they might not be practical for everyone all the time. Blood tests are easier to do often, and could show earlier signs of the cancer. The study is specifically checking two markers in the blood – MCPyV T-Ag antibodies and cell-free miR-375 – to see if they can act as an early warning system, guiding doctors on when more detailed scans might be needed. The aim is to improve the guidelines used across Europe for monitoring patients with Merkel cell carcinoma.

Key takeaways

This study is researching new blood tests for Merkel cell carcinoma.
The goal is to find ways to detect if the cancer returns earlier.
It could help improve monitoring guidelines for patients in the future.
Participation involves providing extra blood samples during routine visits.
There are no new medicines involved in this research study.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or over. You must have received a new diagnosis of Merkel cell carcinoma that has been confirmed by laboratory tests on a tissue sample. This confirmation ensures that your cancer is definitely Merkel cell carcinoma and not another type.

It's also essential that you understand and agree to take part by providing your written consent. This means a doctor or research nurse will explain everything about the study, and you'll have time to ask questions before signing a form.

There are some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, you would not be eligible. If you are currently involved in any legal proceedings that might affect your ability to take part, you would also be excluded.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently been diagnosed with Merkel cell carcinoma?
Is your Merkel cell carcinoma diagnosis confirmed by lab tests?
Are you able to provide written consent to join the study?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

This study does not involve taking new medications. Instead, it focuses on collecting extra blood samples during your regular check-ups for your Merkel cell carcinoma. You would contribute blood samples over time, starting from when you are first diagnosed.

These blood samples will be used to look for specific markers that the researchers are interested in. The exact number of visits and the total duration would depend on your individual follow-up schedule as determined by your doctor, but it would align with your usual care. You would continue to receive your standard medical care and monitoring for Merkel cell carcinoma as advised by your medical team.

Potential risks and benefits

Taking part in this study could potentially help improve future care for people with Merkel cell carcinoma, as the findings might lead to better ways of monitoring the disease. The main involvement is providing blood samples, which carries a very small risk, similar to any standard blood test – a brief discomfort from the needle, and rarely, a small bruise or slight infection. There is no direct benefit to you personally from these experimental blood tests during the course of the study, as they are for research purposes. You are free to withdraw from the study at any time without explaining why, and this will not affect the quality of your medical care.

Locations (10)

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

Common questions

What is Merkel cell carcinoma?

It's a rare and aggressive type of skin cancer that doctors are constantly learning more about.

What are 'blood biomarkers'?

These are naturally occurring substances in your blood that doctors can measure to get information about your health or about a disease.

Will I get direct benefit from the new blood tests?

Not directly during the study, as these are for research. However, your participation helps future patients.

Will I need extra appointments?

The study aims to use blood samples collected during your usual hospital visits for your Merkel cell carcinoma follow-up.

Can I leave the study if I change my mind?

Yes, you can withdraw at any time without penalty, and your medical care will not be affected.