Liverpool Head & Neck Centre
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Clinical Trials

As one of our main missions is to enhance the quality and safety of patient care, we have developed a comprehensive trial program to test new ways of diagnosing and treating both common and rare head and neck diseases.

In addition, our translational research studies aim to further understand the biology around why and how head and neck cancers arise, helping us to develop new treatments. At LHNC, we run one of the largest head and neck clinical trial programs in Europe and patients who choose to participate in a trial with us may often receive some of the most advanced treatment plans available internationally.

If you are a referrer, patient, or centre interested in collaborating, please take a look through our database for eligible studies and we would be delighted to hear from you.

Getting Recovery Right After Neck Dissection for Head and Neck Cancer (GRRAND)

Chief Investigators: Professor Toby Smith (University of Warwick, UK) and Professor Stuart Winters (University of Oxford, UK)

Principal Investigator: Mrs Ruth Price

Outline: For adults undergoing neck dissection for head and neck cancer, which recovery strategy is most effective at improving participant-reported shoulder function and most cost effective; a personalised physiotherapy-led rehabilitation intervention (the GRRAND programme) or usual NHS practice post discharge care?

For: · Patients diagnosed with head and neck cancer requiring neck dissection as part of treatment with curative intent.

  • What is the study treatment?

    Personalised physiotherapy-led rehab intervention

    Patient Group

    Inclusion criteria

    • People aged 18 years or over with diagnosed Head and Neck Cancer requiring neck dissection as part of their treatment with curative intent (the neck dissection only has to be part of their operative plan)

    • Able to attend out-patient physiotherapy appointments

    • Provide informed consent

    Exclusion criteria

    • People for whom intensive post-discharge physiotherapy is expected (e.g. scapula/scapula tip and/or latissimus dorsi free flaps or components thereof).

    • People with pre-existing, long term disease affecting the shoulder e.g. hemiplegia

    • People who had a previous neck dissection on the affected side (if they have had a sentinel lymph node biopsy and then have to return for a completion neck dissection they can be included)

    • Previous entry in the present trial

    • Unable to adhere to trial processes

    How many Groups in study?

    • Intervention Group: personalised physiotherapy-led rehab intervention (GRRAND programme)

    • Control Group: standard NHS practice – post discharge care

    Primary endpoint

    Shoulder pain and function at 12-months using the participant-reported Shoulder Pain and Disability Index (SPADI) questionnaire (total score)

    Secondary outcome

    Post-operative pain, function, HRQoL, mental wellbeing, resource use, adverse events at six weeks, six months and 12 months after randomisation based on:

    • SPADI Total score and Painand Disability domains at six weeks and six months post-randomisation.

    • EORTC cancer-specific questionnaires (C30(core) and H&N35(head and neck specific) at six weeks, six and 12-months post-randomisation.

    • EQ-5D-5L at six weeks, three, six and 12-months post-randomisation.

    • Exercise Adherence Rating Scale (EARS) at six weeks post-randomisation only.

    • Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) at six weeks, six and 12-months post-randomisation.

    • Health resource use questionnaire at six weeks, three, six and 12-months post-randomisation.

    • Adverse events and post-operative complications at six weeks, three, six and 12-months post-randomisation.

    Process evaluation of trial processes, intervention mechanisms including exercise adherence measured with the Exercise Adherence Rating Scale for the GRRAND group at physiotherapy discharge, fidelity and context with a multi-methods process evaluation to inform, if appropriate, further implementation.

    Follow up

    Patients will be followed up 12 months after randomisation

    Duration

    1st February 2025 to 28th February 2028

HoT (Hemithyroidectomy or Total Thyroidectomy for "low-risk" thyroid cancers)

Chief Investigator: Professor Dae Kim (The Royal Marsden Hospital, UK)

Principal Investigator: Mr Christopher Loh

Outline: To compare thyroid cancer recurrence, quality of life, surgical morbidities/effects, and cost-effectiveness between total thyroidectomy and hemithyroidectomy (HT) in a national cancer setting

For: T1b-T2 papillary or follicular thyroid cancer, either diagnosed after hemithyroidectomy, or after biopsy.

  • Phase of study

    PHASE III

    What is the study treatment?

    Hemithyroidectomy (HT) or Total Thyroidectomy (TT) for "low-risk" thyroid cancers

    Patient Group

    Inclusion criteria for Group 1 (HT performed prior to diagnosis):

    • Low-risk thyroid cancer as defined by the American Thyroid Association 2015 and 8thAJCC TNM staging criteria:

    • Aged 16 or over

    Papillary thyroid cancer:

    • pT1b-2 (≤4cm)irrespective of molecular genetic markers

    • R0 resection (clinically excised but microscopic R1 resected tumours at discretion of the local MDT)

    • cN0 or pN0, pNX & pN1a (≤5 foci, no extranodal spread)

    • Confined to thyroid or minimal extrathyroidal extension

    • No higher risk histological variants on morphology (small foci allowed at the discretion of the local MDT)

    • No angioinvasion

    • Encapsulated FVPTC with capsular invasion only

    • Micro-PTC (≤1cm)

      • multifocal

      • unifocal with pN1a (≤5 foci; no extranodal spread)

    Follicular thyroid cancer (FTC), including oncocytic or Hürthle cell carcinoma:

    • pT1b-2 (≤4cm)irrespective of molecular genetic markers

      • Minimally invasive, with capsular invasion +/-minimal (≤4 foci) vascular invasion

    • Confined to thyroid or minimal extrathyroidal extension

    Exclusion criteria for Group 1 (HT performed prior to diagnosis):

    • >4cm

    • unifocal pT1a (≤1cm) PTC or FTC (unless pN1a as above)

    • non-invasive encapsulated FVPTC

    • Anaplastic, poorly differentiated or medullary thyroid carcinoma

    • R2

    • gross extrathyroidal extension

    • pT4 or macroscopic tumour invasion of loco-regional tissues or structures

    • pN1a with >5 foci or extranodal spread

    • pN1b

    • M1

    • Aggressive PTC with any of the following features:

      • Widely invasive

      • Poorly differentiated

      • Anaplastic

      • predominance of Tall cell, Columnar cell, Hobnail, Diffuse sclerosing and other higher risk variants

    • FTC, including oncocytic or Hürthle cell cancer with any of the following features:

      • Minimally invasive with extensive vascular invasion (now called encapsulated angioinvasive) (>4 foci)

      • Widely invasive

      • Poorly differentiated

      • Anaplastic

    Inclusion criteria for Group 2 (DTC on cytology or after core biopsy with no prior surgery yet):

    • Aged 16 or over

    • ‘low risk’ differentiated thyroid cancer confirmed by cytology or core biopsy.

    • cT1b-2 irrespective of molecular genetic markers

    • cN0

    • Contralateral lobe without suspicious nodule(s) (U2, or U3/U4 with Thy2 on FNAC)

    Exclusion criteria for Group 2 (DTC on cytology or after core biopsy with no prior surgery yet):

    • M1

    How many Groups in study?

    Two groups of patients will be recruited via thyroid MDT meetings:

    Group 1:

    Patients that have already had a HT for thyroid problems and are then subsequently diagnosed with low risk DTC. Patients will be randomised to:

    • surveillance only

    or

    • a second operation to remove the rest of the thyroid gland (two-stage TT).

    Group 2:

    Patients that have been diagnosed with ‘low risk’ DTC using cytology (Thy5) or core biopsy but no surgery performed yet. Patients will be randomised to:

    • HT

    or

    • TT (single stage)

    Primary endpoint

    Pilot phase: monthly patient accrual rates

    Main trial: 3 year recurrence rate

    Secondary outcome

    • 5 year recurrence rate

    • Risk of loco-regional recurrence

    • Anatomical site of recurrence

    • Number and type of additional investigations and procedures after 1st surgery

    • Surgical outcomes & complications (RLN & Calcium)

    • Requirement for hormone replacement therapy

    • Quality of life

    • Full cost-effective analysis

    • Biochemical recurrence (role of Thyroglobulin (Tg) & rising Tg levels after HT)

    Follow up

    Patients will be followed up 6 months after surgery and then annually for up to 6 ½ years.

    Other related research

    Sub-study conducted by UCL CTC to test the clinical utility of patients completing QoL forms on a web-based app (software) versus the traditional method of paper forms.

LARCH - The LARyngeal Cancer coHort

Chief Investigator: David Hamilton (Newcastle University, UK)

Principal Investigator: Mr Christopher Loh

Outline: To establish a disease database of laryngeal cancer patients

For: Patients with a new diagnosis of larynx cancer

  • Phase of study

    N/A

    What is the study treatment?

    N/A

    Study Objectives

    Primary objectives

    To establish a disease database of laryngeal cancer patients in order to:

    Assess the difference in quality of life, disease specific and overall survival between treatment modalities in early and advanced laryngeal cancer.

    Assess the impact of patient-derived clinical features and tumour factors on treatment outcome (oncological, laryngeal function, quality of life, swallow, voice) in early and advanced laryngeal cancer and use this to develop a risk prediction tool.

    Secondary objectives

    To establish consent processes to allow researchers to re-contact patients for data on long term outcome and survivorship.

    Using the data, establish an initial risk communication tool in the disease.

    To develop the pathway for routine tissue and radiological scan collection for future studies, mapped to outcome.

    Patient Groups

    There are 2 groups in this study

    Inclusion criteria

    Suspected but unconfirmed laryngeal cancer (Group 1)

    Confirmed new diagnosis of laryngeal cancer (Group 2)

    Age over 18

    Capacity to consent

    Ability to understand written and spoken English

    Exclusion criteria

    Recurrence or second head and neck primary cancer

Liverpool Experimental Cancer Medicine Centre (LECMC) Biomarker Discovery Programme

Chief Investigator: Professor Richard Shaw (Liverpool Head & Neck Centre, UK)

Outline: Prospective Sample Collection of head and neck malignancy specimens

For: Presumptive or actual diagnosis of HNSCC or recognised oral premalignant conditions (OPML), including but not exhaustively OED, PVL, and those individuals who have been treated for these conditions in the past.

  • Phase of study

    N/A

    What is the study treatment?

    N/A

    Patient Group

    Inclusion Criteria 
    Presumptive or actual diagnosis of HNSCC or recognised oral premalignant conditions (OPML), including but not exhaustively OED, PVL, and those individuals who have been treated for these conditions in the past. 

    Exclusion Criteria 
    Unable to consent , age under 18 or unable to read or translate patient information sheet and/or consent form.

    How many Groups in study?

    N/A

    Study objectives 

    With this Protocol the LECMC seeks to support current and future projects which: 

    • Investigate (comprising both discovery and validation) potential markers for: 

    - Outcomes after surgery 
    - Response to therapy, including toxicity Early diagnosis 
    - Test feasibility of biomarker analysis to specified time points 

    • Determine cut-off points and definitions for biomarker analysis 

    These biomarkers may be from a variety of sources (tissue, blood, saliva, urine, etc.) and be in a variety of forms. Research towards these goals will potentially allow for development of personalised treatment regimes, stratification of

    Treatment plan

    N/A

RAPTOR

Chief Investigators: Professor Richard Shaw & Mr Mandeep Bajwa (Liverpool Head & Neck Centre, UK)

Outline: Randomised Controlled Trial of PENTOCLO (Pentoxifylline, Tocopherol & Clodronate) in Mandibular Osteoradionecrosis

For: Patients with established mandibular osteoradionecrosis following previous radiotherapy.

  • Phase of study

    PHASE II

    Sample size

    120 participants

    What is the study treatment?

    Control Arm: Standardised Supportive Care (SSC)

    Treatment Arm: PENTOCLO + SSC

    Patient Group

    The target population is patients who have previously been cured of head and neck cancer that have received radiotherapy, and who have ORN of the mandible.

    Inclusion Criteria

    1.       Patients with ORN of the mandible

    2.       Patients considered suitable for medical management

    3.       Written and informed consent obtained from participant and agreement of participant to comply with the requirements of the study

    Exclusion Criteria

    1.       Cannot swallow tablets

    2.       Prior treatment with PENTOCLO or any element thereof within 12 months of the date of randomisation

    3.       Very early ORN (<20 mm2 exposed bone) occurring within 12 months of a dental extraction or other dentoalveolar operation (‘Minor Bone Spicules’ see flowchart below)

    4.       Mandibular pathological fracture secondary to ORN

    5.       Indication for mandible resection- i.e. patient for whom the severity of their ORN symptoms already constitute an indication for mandible resection and reconstruction. Typically, these symptoms will include severe pain, repeated infections, significant mobile pathological fracture or distressing fistula)

    6.       Patient has had definitive resection / reconstruction for mandibular ORN – i.e. no longer has exposed necrotic bone present.

    7.       Pregnancy

    8.       Lactation

    9.       Age <18 years

    10.   Acute infection at site of the necrotic bone.

    11.   Hypersensitivity to other methylxanthines

    12.   Hypocalcaemia

    13.   Participants not willing to follow the contraceptive requirements of the protocol

    14.   Contraindications to PENTOCLO medications:

    a.       Known hypersensitivity, allergy or anaphylaxis to pentoxifylline, tocopherol or sodium clodronate

    b.       Treated hypotension

    c.       Severe coronary artery disease, defined as grade IV of the Canadian Cardiology Society Angina Grading

    d.       Severe cardiac arrythmia, defined as those cases with attributable syncope or heart failure associated; or those with frequent and symptomatic palpitations, breathlessness, dizziness, chest pain, weakness or fatigue.

    e.       Myocardial infarction within 6 months

    f.        Prior history of extensive retinal haemorrhage

    g.       Prior history of intracranial bleeding

    h.       Impaired renal function (Creatinine clearance <30 ml/minute, will be formally assessed only if U&E out of reference)

    i.         Severe liver failure (class B or C Pugh-Child Score, will be formally assessed only if LFT values out of reference)

    j.         Concomitant prescription of anti-platelet agents: clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, NSAIDs, acetylsalicylates (ASA/LAS) including aspirin >75 mg, ticlopidine, dipyridamole. (low dose =<75 mg aspirin is permitted)

    k.       Concomitant prescription of ketorolac, cimetidine, ciprofloxacin, theophylline, estramustine phosphate

    l.         Hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency

    m.     Concomitant prescription other bisphosphonates e.g. risedronate, alendronate, aIbandronate, zoledronic acid, pamidronate, etidronate or prescription of denosusamab

    n.       Concomitant prescription of aminoglycoside antibiotics e.g. gentamicin, tobramycin, amikacin, plazomicin, streptomycin, neomycin, paromomycin

    Primary Endpoint

    The primary aim is to determine if PENTOCLO triple therapy is effective in healing of mandibular ORN

    Secondary outcome

    To evaluate the impact on PENTOCOLO on:

    ·         Deterioration of ORN

    ·         Patients analgesia and antibiotic use

    ·         Patients anthropological measurements

    ·         Severity of disease

    ·         Quality of Life

    ·         Mandibular preservation

    ·         GI tolerability

    ·         Compliance

    ·         Assessment of IMP’s combination safety

     

     

To find out more, please contact:

raptor@liverpool.ac.uk

 

RESCUE

Survival and functional outcomes following salvage surgery for RESidual or reCurrent sqUamous cEll carcinoma of the head and neck

Chief Investigator: Professor Vinidh Paleri (Royal Marsden, UK)

Principal Investigator: Professor Terry Jones

Outline: The RESCUE study is a combined retrospective and prospective multicentre cohort study investigating the survival and functional outcomes in patients undergoing salvage surgery for recurrent, residual, and new primary head and neck squamous cell carcinoma (SCC). Additionally, the RESCUE study will contain an exploratory molecular analysis of consenting patients to assess the relationship between cancer genomics, previous radiotherapy, and recurrence in head and neck cancer.

  • Objectives

    Primary Objective:

    1. Ascertain the 2-year disease-free survival post salvage surgery for recurrent/ residual/ new primary head and neck SCC (split cohort of prospective and retrospective patients)

    Secondary Objectives:

    2. Define the 2- and 5-year overall, disease specific, and local recurrence free survival in retrospectively identified patients undergoing salvage surgery for recurrent/ residual/ new primary head and neck SCC

    3. Define the 2 year overall, disease specific and local recurrence free survival in prospectively identified patients undergoing salvage surgery for recurrent/ residual/ new primary head and neck SCC

    4. Report on gross functional outcomes by documenting rates of gastrostomy and tracheostomy dependence at 1-year post-salvage surgery.

    5. For the prospective cohort assess the overall, speech-related and swallow-related quality-of-life outcomes at pre-operatively and at 6- and 12-months post-surgery using validated questionnaires.

    6. Estimate the rates of close and involved surgical margins across all surgical salvage procedures

    7. Determine the impact of close and involved margins on survival outcomes

    8. Establish the rates of super-selective, selective and modified/ radical salvage neck dissection in clinically N0 and N+ necks

    9. Ascertain how the extent of salvage neck dissection influences survival outcomes.

    10. Estimate the rate of occult nodal metastasis in clinically N0 necks with locally recurrent disease

    11. Describe the impact of neck dissection on survival outcomes in patients with clinically N0 necks with and without subsequent occult nodal disease

    12. Establish the clinical prognostic indicators of negative survival and functional outcomes

    Exploratory molecular analysis:

    13. Assess the molecular makeup of head and neck tumours that have not responded to radiotherapy treatment, or which recur having previously responded.

    14. Comparison of the differences in subclonal architecture, mutational signatures, and loss of heterozygosity between head and neck cancers before and after radiotherapy treatment

    15. Assess changes in plasma circulating tumour DNA before and after salvage surgical procedures 16. Correlate Molecular outcomes with clinical outcomes from the cohort study.

    Eligibility Criteria

    Inclusion Criteria:

    • Aged over 18

    • Previous H&N SCC treated with radiotherapy

    • Recurrent, residual, or new primary SCC of the oropharynx, oral cavity, larynx, and hypopharynx treated with salvage surgery

    • Ability to give informed consent for biological sample collection (prospective/ molecular study participants only)

    Exclusion Criteria:

    • Nasopharyngeal and cutaneous SCC of the H&N

    • Thyroid, salivary gland, and non-squamous cell H&N cancers

    • Presence of distant metastasis (M1) or surgically inoperable T4b tumours

    Planned Sample Size

    300 retrospective patients and 100 prospective patients

    No limitations will be placed on participants in exploratory molecular analysis

    Follow up duration

    Up to 2 years clinical follow up for oncological outcomes for the prospective cohort and up to 5 years for the retrospective cohort.

    Planned Trial Period

    • Retrospective- consecutive patients will be identified and recruited from 1st January 2016 until 31st December 2021 (salvage surgery between these dates).

    • Prospective- identification and recruitment of patients will take place over 15 months from September 2023 until 1st November 2024 inclusive.

    • Prospective patient’s will be followed up for a minimum of two years following their surgery. The proposed end date of the study is 1st November 2026. The overall proposed study duration is 3.5 years.

ReST-HN

Respiratory-Swallow Training in Head and Neck Cancer

Chief Investigator: Dr Michelle Lawton (University of Liverpool)

Outline: Development of a novel respiratory-swallow intervention to improve swallowing difficulties after head and neck cancer

  • Background

    There remains a clinical need to develop novel swallow interventions to improve swallow safety and function, since persistent dysphagia in this population is often resistant to traditional swallow therapies. Training respiratory-swallow coordination via biofeedback offers a potentially effective treatment. However, the equipment needed for this intervention is expensive and demands specialist training for both clinicians and patients. As such, its delivery has been largely restricted to a research context. We aim to develop a respiratory-swallow training intervention using auditory feedback to improve swallow function following HNC. This will not only eliminate the need for equipment and reduce training costs, but will lend itself to community application, ensuring that it is accessible to all.

    Aims

    This study aims to determine when swallows should be verbally cued to elicit optimal respiratory-swallow coordination (exhale-swallow-exhale pattern) in patients with HNC. These data are needed to inform training.

    For

    Patient over the age of 18 years who have completed treatment for head and neck cancer (3 months or more after treatment) and are able to tolerate fluids orally (of any viscosity/thickness).

    Study design

    A repeated-measures study will be conducted to determine when swallows should be prompted to elicit optimal swallow patterning.

    Intervention/experimental tasks

    Participants will be given a simple verbal prompt to swallow fluids at given timepoints (as indicated by instrumentation) within the respiratory cycle.

    Outcomes

    Respiratory-swallow coordination (respiratory-swallow pattern, lung volume at swallow initiation) will be measured by instrumentation at a single time point.

    Exclusion

    Patients with a nasogastric tube, laryngectomy or tracheostomy, known neurological disease/spinal surgery or insult/respiratory disease or disorder impacting on swallow function and/or recent history (within the last 3 months) of aspiration pneumonia.

To find out more, please contact:

Dr Michelle Lawton (michelle.lawton@liverpool.ac.uk)

Funder: National Institute of Health Research (ref 303061)

STARFISH

Chief Investigators: Dr James Tysome and Dr Matthew Smith (University of Birmingham, UK)

Principal Investigator: Mr Ahmed Youssef

Outline: STARFISH is a pragmatic, multicentre, assessor-blinded, 3-arm randomised controlled trial with an internal pilot.

For: Adults with idiopathic sudden sensorineural hearing loss

  • Objectives

    Primary Objectives:

    • To establish the relative effects of oral, intratympanic, or combined oral and intratympanic steroids on hearing recovery in idiopathic sudden sensorineural hearing loss (ISSNHL), when used as first line management.

    Secondary Objectives:

    • To complete a health economic assessment of the different routes of steroid administration.

    • To use participant submitted data to explore the trajectory to hearing recovery.

    What is the study treatment?

    • Oral steroid (Prednisolone) 1mg/kg/day up to 60mg/day for 7 days; Or

    • Intratympanic steroid (Dexamethasone) three intratympanic injections 3.3mg/ml or 3.8mg/ml spaced 7±2 days apart; Or

    • Combined oral (Prednisolone) and intratympanic (Dexamethasone) steroid as described above, with the first intratympanic injection occurring within 4 days of starting oral steroid use.

    How many groups are there in the study?

    3

    Patient Group

    Inclusion Criteria:

    • Adults aged 18 years or over

    • Diagnosis of new-onset ISSNHL- sensorineural hearing loss of 30 decibels (dBHL) or greater occurring within a 3-day period and including 3 contiguous pure-tone frequencies (out of 0.5, 1.0, 2.0, 4.0 kilohertz (kHz)) confirmed with a pure tone audiogram.

    • Onset of hearing loss within four weeks prior to randomisation

    • English spoken as a first or second language

    Exclusion Criteria:

    • Identified cause for hearing loss (not idiopathic) e.g. Meniere’s

    • Bilateral ISSNHL

    • Received prior steroid treatment for the same episode of ISSNHL

    • Medical contraindication to high dose systemic steroids

    • Previous history of psychosis

    • On oral steroid therapy for another condition

    • Known adrenocortical insufficiency other than exogenous corticosteroid therapy

    • Hypersensitivity to the active substance or to any of the excipients

    • Has a systemic infection unless specific anti-infective therapy is employed

    • Has ocular herpes simplex

    • Has ipsilateral acute or chronic active middle ear disease (including acute otitis media, chronic suppurative otitis media and cholesteatoma, excluding dry perforation)

    • Does not have the capacity to provide written informed consent

    Outcome Measures

    Primary Outcome

    • The absolute improvement in pure tone audiogram average at 12-weeks following treatment initiation (calculated at 0.5, 1.0, 2.0, 4.0 kHz dBHL). Conducted by an audiologist blinded to the treatment allocation.

    Secondary Outcomes

    • Functional hearing:

    o SSQ (Speech, Spatial and Qualities of hearing questionnaire)

    o Pure tone audiogram average at 6-week

    o Pure tone audiogram average across 4.0, 6.0 and 8.0 kHz,

    o AB phoneme score

    • High frequency hearing threshold measured by the absolute improvement in pure tone audiogram average across 4.0, 6.0 and 8.0 kHz.

    • Extent of hearing recovery

    • Time to recovery

    • Associated Symptoms: dizziness and tinnitus (VRBQ & TFI).

    • Adverse Events

    • Health Economics (HUI3, ICECAP-A, Resource usage)

    Optional

    • Weekly home hearing tests (speech and pure tone thresholds) online

    Follow Up

    12 weeks

TARGET Head and Neck

Chief Investigator: Professor Christian Ottensmeier, (Liverpool Head and Neck Centre, UK)

Outline: Tissue analysis for understanding head and neck diseases

For: New suspected or confirmed diagnosis of head and neck cancer & non-malignant head and neck diseases

  • Phase of study

    N/A

    What is the study treatment?

    N/A

    Patient Group

    Inclusion criteria

    For the prospective collection of tumour/affected tissue/mucosal tissue/lymph node/lymphoid tissue biopsies and peripheral blood:

    • Suspected or confirmed diagnosis of head and neck cancer, non-malignant head and neck diseases,

    • Patient aged 18 or over

    • Patients with the ability to understand the study requirements and provide written informed consent.

    • Patient scheduled to undergo diagnostic procedure – Direct/Endoscopic/CT or USS guided biopsy/

    • Head and Neck surgery

    Exclusion criteria for dedicated research procedures

    • Patient deemed medically unfit for sample collection

    • Patient with a contraindication for study procedures or sampling

    • The absence/withdrawal of consent

    How many Groups in study?

    N/A

    Primary Endpoint

    The objective of the study proposed here is to define properties of SARS-CoV-2 reactive TRM cells from cancer and non-cancer patients with or without previous SARS-CoV-2 infection and to assess the impact of SARS-CoV-2 infection on anti-tumour and other anti-viral TRM responses. Comparison with virus-reactive circulating T cells will help define features that are specific to tissue-resident T cells. In addition the role of other immune cell types will be examined.

    This project is part of a greater stratified goal of improving the outcome of viral and cancer treatment by optimising choice and efficacy of immunotherapy based on the detailed understanding of the molecular pathology of the individual.

    Treatment plan

    N/A

    Follow up period

    N/A

    Adverse events and SAE’s


    When reported how long etc

    Only during study involvement 

VOTRI

Chief Investigator: Miss Katharine Davies (Liverpool Head & Neck Centre, UK)

Outline: Does short segment voice recording enhance patient triage of suspected head and neck cancer two week wait referrals?

For: Patients with hoarse voice referred to suspected head and neck cancer clinic

  • Phase of study

    N/A

    What is the study treatment?

    N/A

    Patient Group

    Inclusion criteria:

    Patients willing to perform and consent to the following:

    • Have their voice digitally recorded in a clinic room while slowly counting from 1 -20.

    • Have their breath sounds recorded after taking 2 successive sharp inspiratory breaths.

    Exclusion criteria:

    • Patients not wishing to participate.

    • Patients who cannot give consent.

    How many Groups in study?

    N/A

    Aims

    1. To determine the utility of voice recordings in correctly identifying patients with head and neck cancer when combined with patient symptoms and demographics.

    2. To assess the ability of head and neck surgeons to diagnose patients’ underlying laryngeal or oropharyngeal disorders based on an analysis of voice recordings, symptoms and demographics.

    Outcomes

    Correctly risk stratify patients into malignant or benign groups based on clinician validation of voice recordings and clinician review of patient symptoms and demographics as detailed in the standardized GP referral document (NG12).

    Follow up period

    N/A

    Adverse events and SAE’s

    N/A