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
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Dr Jeffery Smith
- 电话号码:0151 334 4000
- 邮箱:jeffery.smith@nhs.net
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
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
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
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.