Identification and Characterization of Circulating Tumor Cells Before and After Treatment in a Cohort of Patients Treated for Resectable Stage I-III Merkel Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 主要终点
- Circulating tumoral cells detection rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
- •Persons under court protection
- •Patients unable to give consent, protected adults, vulnerable persons
- •Stage IV disease or stage I to III disease for which complete remission is not envisaged
结局指标
主要结局
Circulating tumoral cells detection rate
时间窗: 6 weeks or less after the therapeutic sequence of surgery and radiotherapy
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
次要结局
- Change in the number of pre- and post-therapeutic circulating tumoral cells(6 weeks or less after the therapeutic sequence of surgery and radiotherapy)