CancerFlow on FNANCT07739849
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.
A study testing additional research sampling and flow cytometric analysis in people with Cancer and Lymphoma, run by The Clatterbridge Cancer Centre NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- additional research sampling and flow cytometric analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient on a diagnostic pathway for cancer due to lymphadenopathy, with lymphoma one of the differentials
Who cannot join
- Patients unable to consent
- Patients aged <18
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the 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.
- Being tested
- additional research sampling and flow cytometric analysis
- Keywords
- Flow cytometry
- Medical subject headings
- Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional research sampling and flow cytometric analysisDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: additional research sampling and flow cytometric analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Clatterbridge Cancer Centre NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739849
- Sponsor's protocol ID
- C1655
- Other IDs
- 367706
- Acronym
- Flow on FNA
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07739849
- Acronym / sponsor ID
- Flow on FNA / C1655
- Keywords
- Flow cytometry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Clatterbridge Cancer Centre NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Research Sample Collection and Flow Cytometry Analysis | Other | Diagnostic Test: additional research sampling and flow cytometric analysisAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient on a diagnostic pathway for cancer due to lymphadenopathy, with lymphoma one of the differentials
Key exclusion criteria (2 listed)
- Patients unable to consent
- Patients aged <18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| additional research sampling and flow cytometric analysisParticipants 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. | Diagnostic test | Research Sample Collection and Flow Cytometry Analysis |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing additional research sampling and flow cytometric analysis in people with Cancer and Lymphoma, run by The Clatterbridge Cancer Centre NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Jeffery Smith (0151 334 4000, jeffery.smith@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to lymphoma diagnosis (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.