NCT05962944

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 25, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

July 29, 2022

Last Update Submit

July 27, 2023

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Study Arms (3)

Laboratory testing

Slides reviewed in the laboratory to test the platform for suitability prior to involving patients

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.

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.

Device: Olympus Cellsens software

Interventions

Olympus Cellsens softwareDEVICE

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.

Also known as: Microsoft teams
Laboratory testingRemote ROSE at a site external to the laboratoryRemote ROSE on the same site as the laboratory

Eligibility Criteria

Age18 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Participants attending for an ultrasound guided fine needle aspiration of lesions in the head and neck and supraclavicular fossa nodes.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Cornwall Hospital

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cytology fine needle aspiration samples

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Leonie Wheeldon

    Royal Cornwall Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2022

First Posted

July 27, 2023

Study Start

October 25, 2022

Primary Completion

June 15, 2023

Study Completion

July 24, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations

GB(1)