About this trial
The goal of this prospective observational study is to evaluate the presence of circulating tumoral cells in patients over 18 with a stage I-III resectable Merkel cell carcinoma after the initial therapeutic sequence of surgery and radiotherapy. The main question it aims to answer is :
Can any residual disease be found in the form of circulating tumoral cells in blood samples of patients treated with surgery and radiotherapy for a resectable, stage I to III Merkel cell carcinoma ? When possible, the circulating tumoral cells count will be compared to the one realized in a blood sample of the same patient before surgery and radiotherapy.
Participants will :
* Have a blood sample taken before surgery (if the patient is addressed to our center early enough), * Have a blood sample taken immediately after surgery and radiotherapy (for all). * Two additional blood samples will be taken during the 6-months and 12-months visit to set up a biobank.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients at least 18 years old
Patients managed for stage I to III Merkel cell carcinoma,
For whom complete remission by complete surgical resection is planned (group B) or has been achieved recently, within 6 weeks prior to the inclusion visit (group A).
Disqualifiers
Pregnant or breast-feeding women
Failure to obtain written informed consent after a reflection period
Participant in another research study with an ongoing exclusion period
Not affiliated to a social security scheme
Trial population
Patients managed for stage I to III Merkel cell carcinoma, for whom complete remission by complete surgical resection is planned (group B) or has been achieved recently, within 6 weeks prior to the inclusion visit (group A).
Trial design
Treatments tested in this trial
Blood Test
Other interventionResearch and quantification of Circulating Tumor Cells
Treatment groups
Trial outcomes
Primary outcomes
Circulating tumoral cells detection rate
Rate of patients with the presence of at least one CTC detected in the peripheral blood directly after the therapeutic sequence of surgery and radiotherapy, in absolute value
Secondary outcomes
Change in the number of pre- and post-therapeutic circulating tumoral cells
Difference between the number of post-therapeutic CTCs (after surgery and radiotherapy) and the number of pre-therapeutic CTCs (for patients for whom a pre-therapeutic sample was available: group B patients), in absolute value
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: