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基于全幻灯片图像和 CT 放射组学的深度学习系统用于膀胱癌的预后预测

2026年11月5日 更新者:Mingzhao Xiao

Bladder cancer (BLCA), with its diverse histopathological features and varying patient outcomes, poses significant challenges in diagnosis and prognosis. Postoperative survival stratification based on radiomics feature and whole slide image feature may be useful for treatment decisions to improve prognosis. In this research, we aim to develop a deep learning-based prognostic-stratification system for automatic prediction of overall and cancer-specific survival in patients with BLCA.This observational study evaluates a deep learning system that combines CT images and digitized pathology slides to predict outcomes in patients with bladder cancer. It includes a retrospective cohort and a prospective cohort of newly enrolled patients. The prospective cohort will assess the system in patients enrolled during (2024-2026), with follow-up for survival and recurrence.

研究概览

详细说明

Study structure The study includes an initial retrospective phase and a subsequent prospective observational phase involving newly enrolled patients. The two phases are analyzed separately according to the specified analysis plan.

Retrospective phase The retrospective phase included patients from [2012-2024] and was used for model construction. Results from this phase were reported in npj series.

Prospective phase Enrollment of newly recruited patients began on [2024]. The prospective phase follows protocol, with ethics approval from the first affliated hospital of chongqing medical, university. Recruitment is consecutive, as specified in the protocol.

Model evaluation The prospective cohort is used for validation. The model version, preprocessing procedures and prediction thresholds used in this phase. Any model updating using this cohort is documented separately.

Registry update This update distinguishes the retrospective phase from the subsequently enrolled cohort. The prospective phase enrollment dates and the dates of protocol development and ethics approval are reported separately.

研究类型

观察性的

注册 (估计的)

2000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国、400016
        • 招聘中
        • Department of Urology, The First Affiliated Hospital of Chongqing Medical University
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

We included patients who had surgery only or who had neoadjuvant chemotherapy before surgery. We excluded patients with a postoperative diagnosis of non-urothelial carcinoma.

描述

Inclusion Criteria:

  • patients with bladder cancer who had surgery like radical cystectomy or transurethral resection of bladder tumour (TURBT)
  • contrast-CT scan less than two weeks before surgery
  • complete CT image data and clinical data
  • complete whole slide image data

Exclusion Criteria:

  • patients with a postoperative diagnosis of non-urothelial carcinoma
  • poor quality of CT images

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:OTHER

队列和干预

团体/队列
干预/治疗
Retrospective cohort

Patients with bladder cancer included in the retrospective phase of the study, using clinical records, CT images, and whole-slide images obtained during [2012-2024]. This cohort was used for model development and/or validation and was reported in our npj publications.

develop and validate a deep learning system for prognostication prediction in bladder cancer based on CT radiomics and whole slide images.

Prospective cohort of newly enrolled patients

Newly enrolled patients with bladder cancer recruited at four centers between 2024 and2026. Eligibility is assessed at enrollment, and participants are followed according to protocol version and date for the study outcomes. This cohort is distinct from the previously reported retrospective cohort.

develop and validate a deep learning system for prognostication prediction in bladder cancer based on CT radiomics and whole slide images.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Overall survival
大体时间:up to 10 years

the time from the date of surgery to death from any cause or the date of last contact (censored observation) at the date of data cut-off.

up to 10 years

次要结果测量

结果测量
措施说明
大体时间
Recurrence free survival
大体时间:up to 10 years

the time from the date of surgery to the date of first documented disease recurrence. Patients without recurrence at the time of analysis will be censored

up to 10 years
progression-free survival
大体时间:up to 10 years

The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. Also called PFS.

up to 10 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年1月1日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2024年4月25日

首先提交符合 QC 标准的

2024年4月26日

首次发布 (实际的)

2024年4月29日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

The datasets analyzed during the current study are not publicly available due to the privacy of patients but are available from the corresponding author on reasonable request.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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