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Influencing Next-Generation Oncologic Outcomes Through Rapid Integration of Functional Precision Medicine (NOORI): A Feasibility Study of SmartMatch in Rare Gynecologic Cancers

2026年8月5日 更新者：Fred Hutchinson Cancer Center
This study is being done to determine how easy it is to use standard of care (SOC) surgical resections or biopsy for SmartMatch analysis to determine treatment options in advanced gynecological malignancies.

研究概览

地位

招聘中

条件

详细说明

OUTLINE: This is an observational study.

Patients undergo tissue sample collection obtained from standard of care surgical resection or biopsy for SmartMatch laboratory analysis and have their medical records reviewed on study.

研究类型

观察性的

注册 (估计的)

30

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

  • 姓名：Kalyan Banda, MD
  • 电话号码：206-606-2222
  • 邮箱：bkalyan@uw.edu

学习地点

  • 美国
    • Washington
      • Seattle、Washington、美国、98109
        • 招聘中
        • Fred Hutch/University of Washington Cancer Consortium
        • 首席研究员：
          • Kalyan Banda, MD
        • 接触：
          • Kalyan Banda, MD
          • 电话号码：206-606-2222
          • 邮箱：bkalyan@uw.edu

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

Patients with metastatic or unresectable rare gynecologic cancers who are undergoing SOC procedures that yield fresh tumor tissue suitable for SmartMatch functional precision medicine profiling

描述

Inclusion Criteria:

  • Age ≥ 18 years
  • Histologically confirmed rare gynecologic malignancy, including but not limited to those listed
  • Metastatic or unresectable disease, OR disease for which additional systemic therapy is indicated
  • Fresh tumor tissue available from a SOC surgical procedure or biopsy that in the judgment of the treating team will yield adequate viable tumor for SmartMatch analysis
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate organ function to receive systemic therapy as determined by the treating oncologist (protocol does not specify thresholds because therapy is not mandated)
  • Ability to understand and willingness to sign informed consent
  • Willingness to allow data abstraction from the electronic health record for study endpoints

Exclusion Criteria:

  • Lack of tumor tissue suitable for SmartMatch analysis
  • Purely borderline tumors or benign ovarian/uterine neoplasms
  • Any condition that, in the opinion of the treating oncologist or PI, would interfere with receiving systemic therapy
  • Inability to provide informed consent or comply with study procedures

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
Observational - SmartMatch laboratory analysis
Patients undergo tissue sample collection obtained from standard of care surgical resection or biopsy for SmartMatch laboratory analysis and have their medical records reviewed on study.

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
Proportion of participants for whom SmartMatch generates at least one actionable treatment recommendation that is presented at the PMTB within 4 weeks (≤ 28 days) of fresh tissue acquisition
大体时间：From enrollment up to 36 months

An actionable recommendation is defined as:

  1. FDA-approved therapy for any indication or available clinical trial;
  2. Predicted to have activity by SmartMatch functional precision medicine (FPM) and/or genomics;
  3. Endorsed by PMTB as clinically reasonable.
From enrollment up to 36 months

次要结果测量

结果测量
措施说明
大体时间
Implementation Feasibility: Proportion of PMTB-recommended therapies successfully obtained
大体时间：Up to 36 months
Up to 36 months
Implementation Feasibility: Time from PMTB recommendation to first dose of matched therapy
大体时间：Up to 36 months
Up to 36 months
Implementation Feasibility: Time from live tissue collection to SmartMatch report
大体时间：Up to 36 months
Up to 36 months
Implementation Feasibility: Reasons for access failure/delay (insurance denial, clinical decline, etc.)
大体时间：Up to 36 months
Will document reasons for failure or delay (insurance denial, lack of trial access, toxicity concerns, clinical deterioration, patient preference)
Up to 36 months
Proportion of patients achieving growth modulation index (GMI) ≥ 1.3
大体时间：Up to 36 months
Up to 36 months
Proportion of patients achieving progression-free survival on matched therapy (PFSmatched)
大体时间：Up to 36 months
Up to 36 months
Proportion of patients achieving progression-free survival on the prior line of therapy (PFSpast)
大体时间：Up to 36 months
Up to 36 months
Proportion of patients achieving GMI = PFSmatched / PFSpast
大体时间：Up to 36 months
Up to 36 months
Proportion of patients who begin identified treatment pathways following Precision Medicine Tumor Board (PMTB) review
大体时间：Up to 36 months

Proportion of patients falling into each pathway:

  • Genomic-matched therapy implemented
  • Functional/organoid-matched therapy implemented
  • Physician's choice therapy (no matched therapy recommended, not obtainable, or declined)
Up to 36 months

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

Fred Hutchinson Cancer Center

调查人员

  • 首席研究员：Kalyan Banda, MD、Fred Hutch/University of Washington Cancer Consortium

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 (估计的)

2026年9月1日

初级完成 (估计的)

2029年7月1日

研究完成 (估计的)

2029年7月1日

研究注册日期

首次提交

2026年7月23日

首先提交符合 QC 标准的

2026年7月23日

首次发布 (实际的)

2026年7月28日

研究记录更新

最后更新发布 (实际的)

2026年8月6日

上次提交的符合 QC 标准的更新

2026年8月5日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • RG1126428
  • NCI-2026-05123 (注册表标识符：CTRP (Clinical Trial Reporting Program))
  • FHIRB0021265 (其他标识符：Fred Hutch/University of Washington Cancer Consortium)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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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