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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.

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07739849
Acronym
Flow on FNA
Enrollment
200
Registered
2026-07-31
Start date
2026-08-01
Completion date
2028-07-31
Last updated
2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Lymphoma

Keywords

Flow cytometry

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTadditional research sampling and flow cytometric analysis

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.

Sponsors

The Clatterbridge Cancer Centre NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Single-group, prospective diagnostic study in which all participants undergo flow cytometric analysis of an additional sample collected during routine FNA or core biopsy procedures. Diagnostic performance and pathway outcomes will be evaluated.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to lymphoma diagnosisUp to 18 monthsTime 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

Contacts

CONTACTDr Jeffery Smith
jeffery.smith@nhs.net0151 334 4000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026