NCT05909020

Brief Summary

Can a patient-reported symptom-based risk stratification system improve the suspected head and neck cancer (HNC) pathway? Our methodology includes six interlinked work packages to deliver our aim, with EVEREST-HN 1 encompassing the first of these and seeking to optimise a patient-reported symptom inventory for HNC and outline requirement specification for the SYmptom iNput Clinical (SYNC) system.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

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

Study Start

First participant enrolled

March 17, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

October 3, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

May 9, 2023

Last Update Submit

October 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Inventory and specification for the SYmptom iNput Clinical (SYNC) system

    To optimise a patient-reported symptom inventory for HNC and outline requirement specification for the SYmptom iNput Clinical (SYNC) system

    September 2022 - August 2023

Secondary Outcomes (1)

  • To further explore the current suspected HNC pathway and the language used when discussing symptoms.

    September 2022 - August 2023

Study Arms (2)

Patients

Approximately 150 adults referred for suspected HNC will be recruited.

Other: No intervention.

Staff

Approximately 15 ENT and Maxillofacial) clinicians will be recruited.

Other: No intervention.

Interventions

No intervention.

PatientsStaff

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients Recruitment will aim for variation in age, ethnicity, socio-economic status, presenting symptoms. Clinicians Clinical staff involved in HNC diagnosis. Varying in seniority (consultant, registrar) and specialty (ENT, maxillofacial)

You may qualify if:

  • Patients:
  • Adults ≥ 18 years referred via suspected HNC pathway without previous history of HNC
  • Participants willing and able to give informed consent for participation in the study.
  • Clinicians:
  • Staff at participating sites involved in the diagnostic pathway for people with suspected HNC.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

NOT YET RECRUITING

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

RECRUITING

Luton & Dunstable University Hospital

Luton, United Kingdom

RECRUITING

Oxford NHS Foundation Trust

Oxford, United Kingdom

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Vinidh Paleri

    Royal Marsden NHS Foundation Trust

    STUDY CHAIR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

May 9, 2023

First Posted

June 18, 2023

Study Start

March 17, 2023

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

October 3, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations