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临床试验/NCT06908005
NCT06908005已完成不适用

Development and Prognostic Validation of RaFIST: A Radiomics-Based Tool for Intratumoral Fibrosis Stratification in Non-Small Cell Lung Cancer

Jinling Hospital, China1 个研究点 分布在 1 个国家目标入组 508 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
508
试验地点
1
主要终点
DFS (Disease-free survival)

研究概览

简要总结

Patients with suspected Lung cancer who underwent contrast-enhanced CT and pathological examinations at Center 1 between January 2011 and January 2020 and Center 2 between September 2017 and Januray 2020 were eligible for inclusion in this study.The Clinical data, preoperative clinical information, laboratory results, CT images and pathological sections were collected. The investigators also collected the disease-free survival and overall survival time. On the Deepwise multi-modal research platform, the images were semi-automatically segmented and PyRadiomics was used to extract the radiomic features. Fibrosis quantification was performed on picrosirius red (PSR)-stained tissue sections using color deconvolution and binarized collagen signal analysis in ImageJ software. The investigators developed RaFIST, a radiomics-based stratification tool, to noninvasively quantify intratumoral fibrosis in non-small cell lung cancer (NSCLC) using contrast-enhanced CT imaging. And it was further tested on the held-out external test cohort. Discrimination was assessed by using the C-index and area under the receiver operating characteristic curve (AUC).

研究设计

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

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

  • •Solid pulmonary nodule detected on CECT within 3 weeks pre-resection
  • •No history of previous treatment such as chemotherapy, or radiotherapy

排除标准

  • •Unavailable pathological sections
  • •Missing CT images or hard-to-annotate CT images
  • •Undergone anticancer therapy before CT
  • •Loss to follow-up
  • •Concurrent other malignant tumors

结局指标

主要结局

DFS (Disease-free survival)

时间窗: Record from the date of surgery to the date of recurrence or death from any cause, whichever comes first, and assess up to a maximum of 5 years.

DFS was defined as the duration from the date of primary surgery to the first occurrence of recurrence or death from any cause.

次要结局

  • OS (overall survival)(Record from the date of surgery to the date of death from any cause,whichever comes first, and assess up to a maximum of 5 years.)

研究者

发起方
Jinling Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guangming Lu

Professor

Jinling Hospital, China

研究点 (1)

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