NCT04938986招募中不适用
Interest of the Immunoscore® as a Post-operative Complementary Tool for the Detection of the Risk of Recurrence in Patients With Nonmetastatic Colorectal Cancer : Prospective Cohort Comparing the Recommandation for Patient Care According to the Immunoscore® With the Standard Care Decision.
Hospital St. Joseph, Marseille, France4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年4月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Number of cases where the recommendations for patient care according to the Immunoscore® are considered beneficial compared to the standard care decision
研究概览
简要总结
Evaluate the patient care recommandation induced by the IMMUNOSCORE® result
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 80 inclusive;
- •histologically confirmed colon adenocarcinoma;
- •having undergone a curative resection of stage I, II or III colorectal cancer;
- •diagnosed T1 / T2 / T3 / T4 and N0 / N1 / N2;
- •eligible to receive 6 months of adjuvant chemotherapy;
- •having given free, informed and written consent;
- •agreeing to the use of a tumor sample for research purposes;
- •being affiliated to a social security system.
排除标准
- •pregnant or breastfeeding women
- •legal incapacity or physical, psychological, social or geographical conditions preventing the patient from signing the consent or completing the study.
- •history of other solid tumor within 3 years before inclusion, with the exception of in-situ cancer of the cervix and skin cancers (basal or squamous) treated and controlled
- •person subject to a safeguard measure.
结局指标
主要结局
Number of cases where the recommendations for patient care according to the Immunoscore® are considered beneficial compared to the standard care decision
时间窗: 5 years
次要结局
- Replication error (RER) phenotype(6 and 9 months)
- KRAS, NRAS and BRAF mutations(6 and 9 months)
- Ratio of ciruclating tumor DNA level(6 and 9 months)
- Actual survival (patient alive without recurrence, alive with recurrence, dead)(5 years)
研究者
研究点 (4)
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