Head and Neck CancerNCT05909020
EVEREST-HN 1: EVolution of a patiEnt-REported Symptom-based Risk Stratification sySTem
An observational study of Head and Neck Cancer, run by Royal Marsden NHS Foundation Trust at 4 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 165 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 17 Mar 2023to 30 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- Individuals who do not meet the inclusion criteria.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites, 4 recruiting
- Not yet recruiting
Leeds Teaching Hospitals NHS Trust
Leeds
Unknown Unknown
James Moor
- Recruiting
Liverpool University Hospitals NHS Foundation Trust
Liverpool
Shirley Pringle
Katharine Davies
- Recruiting
Luton & Dunstable University Hospital
Luton
Nithin George
Chrysostomos Tornari
- Recruiting
Oxford NHS Foundation Trust
Oxford
Iqbal Mohammed
Stuart Winter
About this study
Official title: EVolution of a patiEnt-REported Symptom-based Risk Stratification sySTem to Redesign the Suspected Head and Neck Cancer Referral Pathway (Phase 1)
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.
Read the detailed description
The EVEREST-HN pathway should be based on a comprehensive understanding of existing HNC diagnostic pathways and what patients and clinicians value in these. The language used within the EVEREST pathway needs to be accessible and optimal to elicit appropriate information.
- Conditions
- Head and Neck Cancer
- Being tested
- No intervention.
- 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.
No intervention.Other
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Approximately 150 adults referred for suspected HNC will be recruited. Receives: Other: No intervention. | |
| Staff | Approximately 15 ENT and Maxillofacial) clinicians will be recruited. Receives: Other: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: September 2022 - August 2023
Secondary outcomes (1)
To further explore the current suspected HNC pathway and the language used when discussing symptoms.
To understand how clinicians decide subsequent steps for patients referred with suspected HNC, the language patients and clinicians use to describe symptoms and patients' and clinicians' views and experiences of the current diagnostic process for HNC. with a focus on what would work for EVEREST-HN study.
Measured: September 2022 - August 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start17 Mar 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds
- Responsible party
- Sponsor
- Investigators
- Vinidh Paleri, Study chair, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909020
- Sponsor's protocol ID
- CCR5683
- Status last verified
- Oct 2023
- First submitted
- 9 May 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVolution of a patiEnt-REported Symptom-based Risk Stratification sySTem to Redesign the Suspected Head and Neck Cancer Referral Pathway (Phase 1)
- ClinicalTrials.gov ID
- NCT05909020
- Acronym / sponsor ID
- CCR5683
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Leeds
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 18 Jun 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.
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.
Detailed description
The EVEREST-HN pathway should be based on a comprehensive understanding of existing HNC diagnostic pathways and what patients and clinicians value in these. The language used within the EVEREST pathway needs to be accessible and optimal to elicit appropriate information.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: No intervention.Approximately 150 adults referred for suspected HNC will be recruited. |
| Staff | – | Other: No intervention.Approximately 15 ENT and Maxillofacial) clinicians will be recruited. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- 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.
- Staff at participating sites involved in the diagnostic pathway for people with suspected HNC.
Key exclusion criteria (1 listed)
- Individuals who do not meet the inclusion criteria.
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 |
|---|---|---|
| No intervention.No intervention. | Other | Patients, Staff |
Primary outcome
Inventory and specification for the SYmptom iNput Clinical (SYNC) system
Time frame: September 2022 - August 2023
To optimise a patient-reported symptom inventory for HNC and outline requirement specification for the SYmptom iNput Clinical (SYNC) system
1 secondary outcome
To further explore the current suspected HNC pathway and the language used when discussing symptoms.
Time frame: September 2022 - August 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Vinidh Paleri study chair
Royal Marsden NHS Foundation Trust
4 sites 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 Cancer, run by Royal Marsden NHS Foundation Trust at 4 sites 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Webb (0208 915 6666, EVEREST-HN@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inventory and specification for the SYmptom iNput Clinical (SYNC) system (time frame: September 2022 - August 2023). 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 3 Oct 2023.