Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Description of the metastatic events and treatments in high risk UM patients and correlation to biomarkers
研究概览
简要总结
Biomarkers search for early diagnosis of liver metastases in patients with uveal melanoma who benefit from a follow-up tailored to their personalized risk of relapse.
详细描述
High risk patients are referred for the medical oncology consultation to organize oncological surveillance after general staging of the disease. Signature of the informed consent of SALOME study, inclusion in the study and risk-adjusted surveillance schedule :
(i) Liver MRI every 6 months performed at the expert center for UM (according to guidelines).
(ii) For enucleated patients, a blood sample (3 x 6 ml EDTA tubes) is taken every 6 months according to the schedule below. Plasma and mononucleated cells will be isolated and preserved for bio-markers research.
- M0 : during the first medical oncology visit.
- At each imaging assessment, every 6 months for at least 5 years (M6 to M60) and 10 years maximum (M120).
- At the diagnosis of metastasis.
- At each significant event during the metastatic disease (surgery, treatment response or progression).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Patient aged of 18 years or more.
- •Patient with uveal melanoma with high metastatic relapse risk defined as :
- •T2b/c/d ou ≥ T3,
- •or chromosom 3 or chromosom 8 abnormality by CGH array.
- •Completion of treatment of the primary tumor ≤ 2 months.
- •Patient able to comply with the schedule of visits and blood samples of the study.
- •Signed informed consent form or legal representative.
排除标准
- •Patient without french social insurance.
- •Any social, medical or psychological condition making the research process impossible.
结局指标
主要结局
Description of the metastatic events and treatments in high risk UM patients and correlation to biomarkers
时间窗: 120 months
metastatic events and treatments reports correlation with their ocrresponding biomarquers
Biological study (lymphocytes)
时间窗: 120 months
lymphocyte phenotype analysis with biological tests
Biological study (ctDNA)
时间窗: 120 months
circulating tumor DNA analysis with biological tests
次要结局
- Biological samples prospective collection (immune-monitoring analyses)(120 months)
- Comparison of clinical and imaging data (MRI)(120 months)
- Comparison of clinical and imaging data (clinical data)(120 months)
- Multivariate analysis of the prognostic value of identifies biomarkers adjusted for clinical and imaging data(120 months)
- Biological samples prospective collection (ctDNA)(120 months)
- Biological samples prospective collection (sequencing analyses)(120 months)
- Univariate analysis of the prognostic value of identified biomarkers(120 months)
- Analysis of discordant cases regarding genomic/tumor size prognostic factors and outcomes(120 months)
- Multivariate analysis of the prognostic value of identifies biomarkers adjusted for clinical and imaging data(120 months)