跳至主要内容
临床试验/NCT05126160
NCT05126160招募中不适用

Immune Score Based Radiomics in Nasopharyngeal Carcinoma (IMRAN Study)

Zhejiang Cancer Hospital5 个研究点 分布在 1 个国家目标入组 494 人开始时间: 2021年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
494
试验地点
5
主要终点
Area Under Curve (AUC)

研究概览

简要总结

In nasopharyngeal carcinoma (NPC), tumor, node and metastasis (TNM) staging system is the main tool for determining treatment strategy and assessment of prognosis. However, the prognoses of patients with the same TNM stage after similar treatment vary widely. The aim of this study is to establish an immune score based radiomic staging system for NPC.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with newly histologically confirmed non-keratinizing/keratinizing carcinoma.
  • ECOG Performance status: 0-1 With normal liver function test (ALT, AST ≤2.5ULN) Renal: creatinine clearance ≥60ml/min Without hematopathy,marrow: WBC >4*109/L, HGB>90G/L, and PLT>100*109/L. Written informed consent

排除标准

  • Contraindications for MRI scan Prior malignancy (except adequately treated carcinoma in-situ of the cervix or · basal/squamous cell carcinoma of the skin) Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume) Patient is pregnant or lactating Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), or emotional disturbance.

结局指标

主要结局

Area Under Curve (AUC)

时间窗: Median follow-up time of 5 years for the whole group

The AUC of the immune score based radiomic staging system

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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