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Flow on FNA/Core Project- Faster Diagnosis for Lymphoma: Utilising Flow Cytometry on FNA Samples of Lymph Nodes to Diagnose Lymphoma in Hours, Not Days. (Flow on FNA)

Short Title Flow on FNA/Core Project Full Title Faster Diagnosis for Lymphoma: Utilising Flow Cytometry on FNA Samples of Lymph Nodes to Diagnose Lymphoma in Hours, Not Days

The current typical pathway for patients with enlarged lymph glands is to undergo a fine needle aspirate (FNA) under ultrasound, which is then reported by histopathology, typically within one week. If it's suspicious for a lymphoma, when the patient returns to clinic, a core/ excision biopsy is arranged. The current waiting time for a biopsy, either surgically or via radiology, is 2-4 weeks. After the biopsy has been performed, the HODS (Haemato-Oncology Diagnostic Service) turn-around time for lymph node biopsy is 2 - 3 weeks (urgent, or routine samples, according to key performance metrics). It is therefore challenging to achieve a 28-day faster diagnosis for lymphoma patients.

The purpose of this project is to perform flow cytometry for immunophenotyping on FNA samples to rapidly screen and potentially identify patients who have lymphoma.

研究概览

详细说明

The patient will undergo a standard of care procedure including FNA (fine needle aspirate) and core biopsy, which are used during the cancer pathway journey to provide diagnosis. However as described, this pathway can take several weeks to reach a diagnosis. Thus, the project is aimed at shortening the time to diagnosis. To achieve this additional samples will be taken at the time of the above procedures. Typically, during an FNA a liquid sample is taken and spread on slides, but additional sample will be placed in a test tube for this project. During core biopsies, typically 3 to 4 cores are taken, and for this project an additional liquid sample will be placed in the test tube, from the same biopsy site. Therefore, for the patient there is no additional procedure, but additional time (less than one minute) will be needed for the operator to perform the additional steps.

The sample taken for this project will then be sent to the HODS laboratory for supplementary processing above standard of care. Flow cytometry, a standard procedure performed on blood samples, and other biological fluids, will then be performed on the project sample. The immunophenotyping is UKAS accredited, but this project will not be at this time, which will be clear on the report, as this is a research sample. However, results which will come back within hours to 1-2 days, will be used by the clinical teams to help guide further tests. The whole pathway will be evaluated and audited, to assess the hypothesis that patients will be diagnosed faster within the cancer pathway.

研究类型

介入性

注册 (估计的)

200

阶段

  • 不适用

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

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

描述

Inclusion criteria

- Patient on a diagnostic pathway for cancer due to lymphadenopathy, with lymphoma one of the differentials

Exclusion criteria

  • Patients unable to consent
  • Patients aged <18

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

  • 主要用途:诊断
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Research Sample Collection and Flow Cytometry Analysis

All participants who consent receive the same study intervention:

Collection of an additional research sample during their routine FNA or core biopsy procedure.

Analysis of that sample using flow cytometry. No randomisation. No comparator/control group. No allocation to different treatment or diagnostic pathways.

Participants undergoing routine diagnostic investigation for suspected lymphoma will provide an additional sample at the time of standard-of-care fine needle aspiration (FNA) or core biopsy. The additional sample will undergo flow cytometric immunophenotyping to evaluate its ability to rapidly identify lymphoma and improve diagnostic pathway outcomes.

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
Time to lymphoma diagnosis
大体时间:Up to 18 months

Time from sample collection to diagnostic result and completion of the diagnostic pathway.

Time Frame: Up to 18 months (or as specified in the final analysis plan). The protocol states the project aims to shorten the diagnostic pathway and improve the 28-day Faster Diagnosis Standard (FDS

Up to 18 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。

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8月1日

初级完成 (估计的)

2027年7月31日

研究完成 (估计的)

2028年7月31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28日

首次发布 (实际的)

2026年7月31日

研究记录更新

最后更新发布 (实际的)

2026年7月31日

上次提交的符合 QC 标准的更新

2026年7月28日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • C1655
  • 367706 (其他标识符:IRAS)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

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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