An observational study in Merkel Cell Carcinoma, sponsored by University Hospital, Montpellier. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-13.
Sponsored by University Hospital, Montpellier · Observational
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 :
The main goal of this study is to evaluate the presence of circulating tumoral cells in patients circulating tumoral cells after surgery and radiotherapy in patients with stage I to III Merkel cell carcinoma.
Another goal will be to track changes in the number of circulating tumoral cells before and after treatment in patients with stage I to III Merkel cell carcinoma, who have had a blood sample taken before starting treatment.
Investigators will also set up a biobank, which is a collection of blood samples taken every six months for one year. These samples will help with future research.
The study will include patients over 18 years old with stage I to III Merkel cell carcinoma, treated at the Dermatology Departments of Montpellier and Nimes University Hospitals. Investigators will not include pregnant or breastfeeding women, patients not covered by social security, those under court protection, those unable to give consent, or those with stage IV Merkel cell carcinoma or stage I to III Merkel cell carcinoma where complete remission is not possible. All patients will give free and informed consent to participate.
Patients will be divided into two groups based on when they are referred to the university hospital for treatment.
Group A: If the tumor is fully removed before the patient is referred to the hospital.
Group B: If the tumor is still present when referred to the hospital. This can happen if:
Both groups will have follow-up visits at 6 and 12 months. The main endpoint will be the circulating tumoral cell detection rate, which is the presence of circulating tumoral cells in their blood right after surgery and radiotherapy. Another measure will be the change in the number of circulating tumoral cells before and after treatment for those who had a blood sample taken before starting treatment.
138 studies on the registry are indexed under Carcinoma, Merkel Cell; 39 are open to participants now.
This study's planned enrollment of 25 is below the median of 307 across 10 observational studies indexed under Carcinoma, Merkel Cell.
Browse Carcinoma, Merkel Cell studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 227 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
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Exclusion Criteria:
Entire cohort
Other: Blood Test
Research and quantification of Circulating Tumor Cells
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
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2024; primary completion for Jan 2026, 18 months later.
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This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier →