NCT04866680进行中（未招募）不适用
Personalized Circulating DNA Follow-up in Melanoma
Institut de Cancérologie de Lorraine8 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2023年1月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 136
- 试验地点
- 8
- 主要终点
- Studying the tumor molecular abnormalities resulting from circulating tumor DNA (ctDNA) to predict the resistance to treatment
研究概览
简要总结
PERCIMEL is an open multicentric study. The purpose of this study is to assess the interest of molecular analysis on circulating tumor DNA in the follow-up of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Adult patient;
- •ECOG performance status 0-2;
- •Patient with melanoma stage IIB or IIC, or any stage III, or stage IV that has been resected or is resectable;
- •Treatment-naïve patient (except for initial excisional biopsy performed for diagnostic purposes);
- •Patient scheduled to receive adjuvant therapy within 12 weeks following surgery, consisting of anti-BRAF and anti-MEK kinase inhibitors or anti-PD-1 monoclonal antibody immunotherapy, in accordance with marketing authorization;
- •Patient with stage IIIB, IIIC, IIID, or IV melanoma with macroscopic lesions (clinically or radiologically detectable) eligible for neoadjuvant therapy, surgery, and adjuvant therapy (according to current recommendations: ESMO and NCCN guidelines, and treatment regimens from the SWOG S1801 and NADINA studies);
- •Biological parameters compatible with the planned treatment;
- •Patient informed and having provided written informed consent.
排除标准
- •Patient with mucosal melanoma or choroidal (uveal) melanoma;
- •Patient with another synchronous malignancy or who has been treated for another malignancy within the 3 years preceding informed consent (except carcinoma in situ of the cervix or resected cutaneous carcinoma);
- •Contraindication to a 30 mL blood sample;
- •Contraindication to surgery;
- •Contraindication to the proposed medical treatment (anti-BRAF and anti-MEK targeted therapies or immunotherapy);
- •Patient participating in another clinical trial involving an investigational medicinal product;
- •Pregnant or breastfeeding woman;
- •Patient deprived of liberty (including those under legal guardianship or curatorship).
研究组 & 干预措施
Personalized Circulating DNA follow-up
Experimental
FFPE tissue sample + blood sample (20ml)
干预措施: Personalized Circulating DNA follow-up (Procedure)
结局指标
主要结局
Studying the tumor molecular abnormalities resulting from circulating tumor DNA (ctDNA) to predict the resistance to treatment
时间窗: 24 months
Quantity of ctDNA / Resistance to treatment defined as a change in treatment decided during staff meeting
次要结局
未报告次要终点
研究者
研究点 (8)
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