Head and Neck NeoplasmsRemote ROSENCT05962944
Remote Rapid Onsite Evaluation (ROSE) for Head and Neck Fine Needle Aspirations (FNA)
An observational study of Head and Neck Neoplasms, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
Trial summary
Rapid On-Site Evaluation (ROSE) of cytology FNA samples performed by a Pathologist or Biomedical Scientist is a real time morphological assessment of the sample in the clinical setting with the aim of acquiring all the diagnostic material in one appointment resulting in reduction in costs, improved patient care and… Read more about this study
- Who is it for?
- Ages 18 to 19 years
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Olympus Cellsens software
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Oct 2022to 24 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 19 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants attending for an ultrasound guided fine needle aspiration of lesions in the head and neck and supraclavicular fossa nodes.
Who may be able to join
- Male and female participants > 18-90 years of age
- Participants attending for an ultrasound guided fine needle aspiration of lesions in the head and neck and supraclavicular fossa nodes.
- All ethnicity or socioeconomic grouping that require an US FNA at RCHT over the 12-month study period.
- Able and willing to consent to the study
Who cannot join
- Anyone <18 years of age
- Patients that do not require an FNA after the initial ultrasound
- Any participants considered vulnerable will not be included in the study.
- This study involves testing the concept of remote ROSE rather than direct impact on patient care needs related to ethical of communication issues. For practical considerations and to prevent unnecessary anxiety for patients who are unable to read the information sheets and provide consent, these patients will not be included in the study.
- Unable or unwilling to consent to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Rapid On-site Evaluation (ROSE) for Head and Neck Fine Needle Aspirations (FNA)
Rapid On-Site Evaluation (ROSE) of cytology FNA samples performed by a Pathologist or Biomedical Scientist is a real time morphological assessment of the sample in the clinical setting with the aim of acquiring all the diagnostic material in one appointment resulting in reduction in costs, improved patient care and reduced referral to treatment time.
It is not practical or possible for the ROSE team to be present in every location where an FNA is performed. Telecytology (TC) or remote ROSE is a digital form of ROSE which allows a biomedical scientist or pathologist working in a remote laboratory to review the cytology slides in real time, using microscope images fed from the location where the FNA procedure is being performed.
Read the detailed description
The new faster diagnostic standards (FDS) alongside NICE guidance and the British association of Head and Neck Oncologists (BAHNO) guidelines, state that ROSE should be provided for all FNA's. It is not practical or possible for the ROSE team to be present in every location where an FNA is performed. Telecytology (TC) or remote ROSE is a digital form of ROSE which allows a biomedical scientist or pathologist working in a remote laboratory to review the cytology slides in real time, using microscope images fed from the location where the FNA procedure is being performed.
A trained a clinical imaging assistant (CIA) will prepare the slides and drive the microscope in the ultrasound room. Using the Olympus software Cellsens and the screen share option in Microsoft teams, the remote biomedical scientist / pathologist will be able to assess the sample in real time and provide both verbal and written methods of communication (relevant clinical information and instructions). An additional camera will allow visualisation of the slide preparation and residual material in real time to the scientist / pathologist performing the assessment.
This study will investigate whether ROSE can be performed remotely. This study will be based in the cytology department at the Royal Cornwall Hospital as part of a service improvement. Phase 2 will involve the use of the Tower Block ultrasound room located on the Royal Cornwall Hospitals Truro site and in phase 3 the ultrasound room at The Royal Cornwall Hospital's Camborne and Redruth site.
Patients between the ages of 18 and 90 years attending for an ultrasound guided fine needle aspiration of lesions in the head and neck and supraclavicular fossa nodes will be consented for remote ROSE to be performed over a 12-month period.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Olympus Cellsens software
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olympus Cellsens softwareDevice
Also called Microsoft teams
Olympus cellsens software will be used to visualise the cells and MS teams screen share will be used to send the live images in real time.
| Study group | Role | What they receive |
|---|---|---|
| Laboratory testing | Slides reviewed in the laboratory to test the platform for suitability prior to involving patients Receives: Device: Olympus Cellsens software | |
| Remote ROSE on the same site as the laboratory | The next phase will involve remote ROSE being performed on the same site as the laboratory in an ultrasound room located on the Royal Cornwall Hospitals Truro site. Receives: Device: Olympus Cellsens software | |
| Remote ROSE at a site external to the laboratory | Phase 3 will involved remote ROSE being performed on a different site to the laboratory. The ultrasound room at The Royal Cornwall Hospital's Camborne and Redruth site. Receives: Device: Olympus Cellsens software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid on site evaluation can be provided using telecytology
To robustly test the concept of remote rapid on site evaluation for head and neck.
The Scientist performing the remote ROSE will record the assessment findings:
- Inadequate sampling - Advise repeat sampling
- Adequate sampling - Stop procedure.
- Diagnostic sampling but more material required. - Advise repeat sampling
- Diagnostic sampling and sufficient cell yield - Stop procedure These findings will be compared with the final diagnostic outcomes (Final report) issued by the laboratory. The overall effectiveness of remote ROSE will be compared against current practice for head and neck FNA in terms of adequacy and diagnostic yield. If over 80% of samples obtained with remote ROSE are deemed adequate and sufficient then the trial will be regarded as successful. This prevents the majority of patients having to return for additional appointments and procedures.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start25 Oct 2022
- Primary completion15 Jun 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Cornwall Hospitals Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonie Wheeldon, Principal investigator, Royal Cornwall Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962944
- Sponsor's protocol ID
- RoyalCornwallHT
- Acronym
- Remote ROSE
- Status last verified
- Jul 2023
- First submitted
- 29 Jul 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Rapid On-site Evaluation (ROSE) for Head and Neck Fine Needle Aspirations (FNA)
- ClinicalTrials.gov ID
- NCT05962944
- Acronym / sponsor ID
- Remote ROSE / RoyalCornwallHT
- Conditions
- Head and Neck Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Royal Cornwall Hospitals TrustUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 27 Jul 2023 (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.
Rapid On-Site Evaluation (ROSE) of cytology FNA samples performed by a Pathologist or Biomedical Scientist is a real time morphological assessment of the sample in the clinical setting with the aim of acquiring all the diagnostic material in one appointment resulting in reduction in costs, improved patient care and reduced referral to treatment time.
It is not practical or possible for the ROSE team to be present in every location where an FNA is performed. Telecytology (TC) or remote ROSE is a digital form of ROSE which allows a biomedical scientist or pathologist working in a remote laboratory to review the cytology slides in real time, using microscope images fed from the location where the FNA procedure is being performed.
Detailed description
The new faster diagnostic standards (FDS) alongside NICE guidance and the British association of Head and Neck Oncologists (BAHNO) guidelines, state that ROSE should be provided for all FNA's. It is not practical or possible for the ROSE team to be present in every location where an FNA is performed. Telecytology (TC) or remote ROSE is a digital form of ROSE which allows a biomedical scientist or pathologist working in a remote laboratory to review the cytology slides in real time, using microscope images fed from the location where the FNA procedure is being performed.
A trained a clinical imaging assistant (CIA) will prepare the slides and drive the microscope in the ultrasound room. Using the Olympus software Cellsens and the screen share option in Microsoft teams, the remote biomedical scientist / pathologist will be able to assess the sample in real time and provide both verbal and written methods of communication (relevant clinical information and instructions). An additional camera will allow visualisation of the slide preparation and residual material in real time to the scientist / pathologist performing the assessment.
This study will investigate whether ROSE can be performed remotely. This study will be based in the cytology department at the Royal Cornwall Hospital as part of a service improvement. Phase 2 will involve the use of the Tower Block ultrasound room located on the Royal Cornwall Hospitals Truro site and in phase 3 the ultrasound room at The Royal Cornwall Hospital's Camborne and Redruth site.
Patients between the ages of 18 and 90 years attending for an ultrasound guided fine needle aspiration of lesions in the head and neck and supraclavicular fossa nodes will be consented for remote ROSE to be performed over a 12-month period.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laboratory testing | – | Device: Olympus Cellsens softwareSlides reviewed in the laboratory to test the platform for suitability prior to involving patients |
| Remote ROSE on the same site as the laboratory | – | Device: Olympus Cellsens softwareThe next phase will involve remote ROSE being performed on the same site as the laboratory in an ultrasound room located on the Royal Cornwall Hospitals Truro site. |
| Remote ROSE at a site external to the laboratory | – | Device: Olympus Cellsens softwarePhase 3 will involved remote ROSE being performed on a different site to the laboratory. The ultrasound room at The Royal Cornwall Hospital's Camborne and Redruth site. |
Who may qualify
- Ages
- 18 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants attending for an ultrasound guided fine needle aspiration of lesions in the head and neck and supraclavicular fossa nodes.
Key inclusion criteria (4 listed)
- Male and female participants > 18-90 years of age
- Participants attending for an ultrasound guided fine needle aspiration of lesions in the head and neck and supraclavicular fossa nodes.
- All ethnicity or socioeconomic grouping that require an US FNA at RCHT over the 12-month study period.
- Able and willing to consent to the study
Key exclusion criteria (5 listed)
- Anyone <18 years of age
- Patients that do not require an FNA after the initial ultrasound
- Any participants considered vulnerable will not be included in the study.
- This study involves testing the concept of remote ROSE rather than direct impact on patient care needs related to ethical of communication issues. For practical considerations and to prevent unnecessary anxiety for patients who are unable to read the information sheets and provide consent, these patients will not be included in the study.
- Unable or unwilling to consent to the study
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 |
|---|---|---|
| Olympus Cellsens softwareAlso: Microsoft teamsOlympus cellsens software will be used to visualise the cells and MS teams screen share will be used to send the live images in real time. | Device | Laboratory testing, Remote ROSE at a site external to the laboratory, Remote ROSE on the same site as the laboratory |
Primary outcome
Rapid on site evaluation can be provided using telecytology
Time frame: 12 months
To robustly test the concept of remote rapid on site evaluation for head and neck. The Scientist performing the remote ROSE will record the assessment findings: * Inadequate sampling - Advise repeat sampling * Adequate sampling - Stop procedure. * Diagnostic sampling but more material required. - Advise repeat sampling * Diagnostic sampling and sufficient cell yield - Stop procedure These findings will be compared with the final diagnostic outcomes (Final report) issued by the laboratory. The overall effectiveness of remote ROSE will be compared against current practice for head and neck FNA in terms of adequacy and diagnostic yield. If over 80% of samples obtained with remote ROSE are deemed adequate and sufficient then the trial will be regarded as successful. This prevents the majority of patients having to return for additional appointments and procedures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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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. This study is not recruiting at the moment.
Leonie Wheeldon principal investigator
Royal Cornwall Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rapid on site evaluation can be provided using telecytology (time frame: 12 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 1 Aug 2023.