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Acute Risk Monitoring for Oncology Therapy Regimen (ARMOR)

2026年5月15日 更新者:University of California, San Francisco

Acute Risk Monitoring for Oncology Therapy Regimens (ARMOR): A Silent Prospective Validation of a Machine Learning Model

Patients undergoing outpatient infusion systemic therapy for cancer are at risk for potentially preventable, unplanned acute care in the form of emergency department (ED) visits and hospitalizations. These events impact patient outcomes, treatment decisions, and healthcare costs. To address this need, the Centers for Medicare & Medicaid Services developed the chemotherapy measure (OP-35). Recent randomized controlled studies indicate that electronic health record (EHR)-based machine learning (ML) approaches accurately direct supportive care to reduce acute care during radiotherapy. This study aims to develop and prospectively validate ML approaches to predict the risk of OP-35 qualifying, potentially preventable, acute care events within 30 days of infusion systemic therapy.

研究概览

详细说明

OBJECTIVES:

I. Develop and retrospectively validate electronic health record-based machine learning models using routinely collected clinical data from patients receiving systemic therapy to predict risk of potentially preventable OP-35 qualifying acute care events. (Phase 1: Retrospective)

II. Prospectively validate machine learning models across distinct time periods. (Phase 2: Prospective)

III. Understand patterns of care by stratifying and analyzing model performance by treatment type, cancer diagnosis, and race/ethnicity to assess bias and disparities in outcomes.

OUTLINE:

Retrospective and prospective clinical data obtained from medical records will be used to develop and validate predictive machine learning models. Prospective data will be divided into 2 phases: Prospective validation (PV) 1 and PV 2.

研究类型

观察性的

注册 (实际的)

4740

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。

学习地点

    • California
      • San Francisco、California、美国、94143
        • University of California, San Francisco

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

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adult patients receiving care for cancer

描述

Inclusion Criteria:

  • Patients 18 years or older diagnosed with cancer who receive care at UCSF and/or one of the UCSF affiliate locations.

Exclusion Criteria:

  • Patients under the age of 18.
  • Patients receiving care as part of a clinical trial.

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

队列和干预

团体/队列
干预/治疗
Patients receiving cancer therapy at University of California, San Francisco (UCSF)
All adults undergoing systemic cancer-related therapy from July 2017 to March 2024 at any UCSF outpatient, infusion center with available OP-35 data.
Retrospective chart reviews for data collection will be conducted.

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
Area under the receiver operating characteristic curve (AUROC) for OP-35 prediction model.
大体时间:Up to 6.75 years
UCSF patients receiving infusion systemic therapy had clinical data incorporated into machine learning (ML) models to predict risk of Centers for Medicare & Medicaid Services Chemotherapy Measure (OP-35) qualifying acute care events within 30 days of infusion. Models included variables such as cancer diagnosis, therapeutic agents, and laboratory values. Three ML approaches were employed to train models in predicting OP-35 events. Models were trained and retrospectively validated on data from July 7, 2017, to February 11, 2021, and prospectively validated on 2 cohorts: April 17, 2023, to October 29, 2023 (PV1) and February 19, 2024, to March 31, 2024 (PV2) to generate a validation AUROC. The initial prospective validation occurred over a pre-planned period with the assumption of a 2% event rate, based on the model development data, with an alpha of 0.05 and 84% power to detect an AUROC of 0.75, requiring a sample size of at least 8000 infusions.
Up to 6.75 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。

调查人员

  • 首席研究员:Julian Hong, MD, MS、University of California, San Francisco

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)

2017年7月1日

初级完成 (实际的)

2024年3月31日

研究完成 (实际的)

2024年3月31日

研究注册日期

首次提交

2026年5月15日

首先提交符合 QC 标准的

2026年5月15日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月15日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 20721 (注册表标识符:DAIDS-ES Registry Number)
  • R01CA277782 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

De-identified data may be shared with study collaborators during the course of the study.

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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