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.

NCT07739849 | Not Yet Recruiting DMC

• 2 other identifiers: C1655367706
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer; Lymphoma

Keywords

Flow cytometry

Outcome Measures

Primary Outcomes (1)

• Time to lymphoma diagnosis

  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

Study Arms (1)

Research Sample Collection and Flow Cytometry Analysis

OTHER

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.

Diagnostic Test: additional research sampling and flow cytometric analysis

Interventions

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.

Research Sample Collection and Flow Cytometry Analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients unable to consent
• Patients aged \<18

Sponsors & Collaborators

• The Clatterbridge Cancer Centre NHS Foundation Trust: lead

MeSH Terms

Conditions

Neoplasms; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Dr Jeffery Smith

CONTACT

0151 334 4000; jeffery.smith@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07