Identification and Characterization of Circulating Tumor Cells Before and After Treatment (Surgery and Radiotherapy) in a Cohort of Patients Treated for Resectable Stage I-III Merkel Cell Carcinoma

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

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 volunteers

Qualifiers

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 intervention

    Research and quantification of Circulating Tumor Cells

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Cohort of Patients Treated for Resectable Stage I-III Merkel Cell Carcinoma1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
6 weeks or less after the therapeutic sequence of surgery and radiotherapy

Secondary outcomes

1

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

Time frame
6 weeks or less after the therapeutic sequence of surgery and radiotherapy

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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