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NCT Number: NCT07739849

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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

additional research sampling and flow cytometric analysis

Diagnostic Test

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.

Primary outcomes

  1. Time to lymphoma diagnosis

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Jeffery Smith

CONTACT

[email protected]

0151 334 4000

Sponsors and collaborators

Lead sponsor

The Clatterbridge Cancer Centre NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: Flow on FNA

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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