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.

ConditionsCancerLymphoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Clatterbridge Cancer Centre NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients unable to consent

Patients aged <18

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Research Sample Collection and Flow Cytometry AnalysisOther 1 intervention

Trial outcomes

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

Time frame
Up to 18 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: