Head and Neck CancerHERDNCT05097625
Head and Neck Early Relapse Detection Study (HERD)
An observational study of Head and Neck Cancer, run by University College, London at 1 site in United Kingdom.
Trial summary
Head and neck squamous cell carcinoma is the 6th most common cancer worldwide with an annual incidence of 12000 cases in the UK alone. More than 60% of cases are diagnosed at the locally advanced stage. These patients are treated with radical intent, using a combination of surgery, radiotherapy and/or chemotherapy. 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
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jul 2023to 15 Jul 2026
- 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: The study population will be adults, aged 18 years and over with histologically confirmed, locally advanced HNSCC, who are HPV negative and considered of intermediate or high risk, and will be offered radical treatment. This includes surgery and any postoperative adjuvant/consolidation treatment, or radical chemo-radiation.
Who may be able to join
- Histologically confirmed, locally advanced HNSCC, HPV negative considered as intermediate or high risk .
- Offered radical treatment. (This includes surgery and any postoperative adjuvant/consolidation treatment, or radical chemo-radiation).
- Age ≥ 18 years.
- Adequate bone marrow function (nNeutrophils, platelets and haemoglobin grade 0 or 1 according to CTCAE).
Who cannot join
- HPV positive disease.
- Participants with concurrent malignancy.
- Confirmed distant metastatic disease on most recent imaging scan.
- Known Hepatitis B, C or HIV infection .
- Contraindications to MRI (including but not limited to cardiac pacemaker, metallic implants, major claustrophobia).
- Pregnant and lactating patients.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas'
London
About this study
Official title: A Prospective Cohort Study of Patients With Radically Treated Newly Diagnosed Locally Advanced HPV Negative Head and Neck Cancer to Develop and Validate a Multimodal Signature to Risk-stratify for Recurrence
Head and neck squamous cell carcinoma is the 6th most common cancer worldwide with an annual incidence of 12000 cases in the UK alone. More than 60% of cases are diagnosed at the locally advanced stage. These patients are treated with radical intent, using a combination of surgery, radiotherapy and/or chemotherapy. Unfortunately 5 in 10 patients relapse within 2 years, with most relapses occurring within the first year since treatment.
Unlike many other solid tumours, 80% of relapses occur locoregionally. Salvage surgery offers the best chance of long-term survival for patients with loco-regional recurrence, but this is only possible if the recurrence is amenable to resection. Salvage surgery has been estimated to improve survival outcomes in relapsed cancer by up to 73%. For salvage surgery to be feasible, relapses need to be detected early. Current surveillance strategies have little evidence base, with imaging often driven by clinical symptoms - often when the recurrence is no longer amenable to salvage surgery.
With this study, we will address the unmet clinical need to develop a risk-stratified surveillance pathway to enhance detection of early relapse of radically treated head and neck cancer. At present, tumour grade and biomarkers such as HPV status have offered important but insufficient information to guide surveillance strategies.
Read the detailed description
AIMS: We hypothesise that risk of relapse relies on a dynamic interplay between the immune profile, tumour microenvironment, genetic signature and clinicopathological characteristics of the participant receiving treatment. Based on the recruitment of 200 participants within the study, we aim to generate sufficient evidence to guide a multi-analyte-based stratified imaging surveillance/follow up strategy to detect early relapse of cancer and improve survival. We will also develop a biorepository of data across a range of modalities to guide individualised treatment by precision medicine.
OBJECTIVES: The primary objective is to develop and validate a multimodal signature to risk-stratify participants with radically treated head and neck cancer into different surveillance pathways. Non-invasive methods of surveillance, such as blood and saliva tests, will be used to monitor for relapse, with any abnormalities triggering imaging. This will facilitate early detection of relapse and facilitate salvage surgery, leading to better survival outcomes.
DESIGN: This is a prospective cohort study of participants with newly diagnosed locally advanced HPV negative head and neck cancer, deemed to be intermediate or high risk (Figure 2A), referred to secondary care for radical treatment.
- Conditions
- Head and Neck Cancer
- 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.
| Study group | Role | What they receive |
|---|---|---|
| High Risk Pathway | Risk-stratified surveillance pathway, including non-invasive methods of surveillance such as blood and saliva tests; to monitor for relapse, with any abnormalities triggering imaging | |
| Low Risk Pathway | Risk-stratified surveillance pathway, including non-invasive methods of surveillance such as blood and saliva tests; to monitor for relapse, with any abnormalities triggering imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Was a multimodal signature developed to risk-stratify participants with locally advanced radically treated head and neck cancer?
Yes or No
Measured: 4 years (data collection period)
Secondary outcomes (1)
Was a non-invasive method of surveillance successfully developed?
Yes or No
Measured: 4 years (data collection period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start12 Jul 2023
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK
- Responsible party
- Sponsor
- Investigators
- Martin Forster, Dr, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097625
- Sponsor's protocol ID
- 277885
- Acronym
- HERD
- Status last verified
- Oct 2023
- First submitted
- 8 Sep 2021
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mithra S, Ahmed AA, Roshan A, Barber PR, de Carvalho Gomes C, Coolen T, Sawyer E, Rosenfeld N, Sinkus R, Reis-Ferreira M, Connor S, Shmueli K, Morley S, Nenclares P, Apsey C, Hackshaw A, Arora A, Beeston T, Tuazon J, Berin M, Yeung A, Curtis C, Ng K, Mustapha R, Gillett C, Issa B, Brew-Graves C, Lioumi M, Ng T, Forster M. Multimodality detection of early relapse in radically treated high-risk HPV-negative head and neck squamous cell carcinoma: study protocol for a prospective multicentre UK cohort study (HERD). BMJ Open. 2026 Sep 24;16(9):e121924. doi: 10.1136/bmjopen-2026-121924.
PubMed 42785937
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Patients With Radically Treated Newly Diagnosed Locally Advanced HPV Negative Head and Neck Cancer to Develop and Validate a Multimodal Signature to Risk-stratify for Recurrence
- ClinicalTrials.gov ID
- NCT05097625
- Acronym / sponsor ID
- HERD / 277885
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Cancer Research UK
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 28 Oct 2021 (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.
Head and neck squamous cell carcinoma is the 6th most common cancer worldwide with an annual incidence of 12000 cases in the UK alone. More than 60% of cases are diagnosed at the locally advanced stage. These patients are treated with radical intent, using a combination of surgery, radiotherapy and/or chemotherapy. Unfortunately 5 in 10 patients relapse within 2 years, with most relapses occurring within the first year since treatment.
Unlike many other solid tumours, 80% of relapses occur locoregionally. Salvage surgery offers the best chance of long-term survival for patients with loco-regional recurrence, but this is only possible if the recurrence is amenable to resection. Salvage surgery has been estimated to improve survival outcomes in relapsed cancer by up to 73%. For salvage surgery to be feasible, relapses need to be detected early. Current surveillance strategies have little evidence base, with imaging often driven by clinical symptoms - often when the recurrence is no longer amenable to salvage surgery.
With this study, we will address the unmet clinical need to develop a risk-stratified surveillance pathway to enhance detection of early relapse of radically treated head and neck cancer. At present, tumour grade and biomarkers such as HPV status have offered important but insufficient information to guide surveillance strategies.
Detailed description
AIMS: We hypothesise that risk of relapse relies on a dynamic interplay between the immune profile, tumour microenvironment, genetic signature and clinicopathological characteristics of the participant receiving treatment. Based on the recruitment of 200 participants within the study, we aim to generate sufficient evidence to guide a multi-analyte-based stratified imaging surveillance/follow up strategy to detect early relapse of cancer and improve survival. We will also develop a biorepository of data across a range of modalities to guide individualised treatment by precision medicine.
OBJECTIVES: The primary objective is to develop and validate a multimodal signature to risk-stratify participants with radically treated head and neck cancer into different surveillance pathways. Non-invasive methods of surveillance, such as blood and saliva tests, will be used to monitor for relapse, with any abnormalities triggering imaging. This will facilitate early detection of relapse and facilitate salvage surgery, leading to better survival outcomes.
DESIGN: This is a prospective cohort study of participants with newly diagnosed locally advanced HPV negative head and neck cancer, deemed to be intermediate or high risk (Figure 2A), referred to secondary care for radical treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Risk Pathway | – | –Risk-stratified surveillance pathway, including non-invasive methods of surveillance such as blood and saliva tests; to monitor for relapse, with any abnormalities triggering imaging |
| Low Risk Pathway | – | –Risk-stratified surveillance pathway, including non-invasive methods of surveillance such as blood and saliva tests; to monitor for relapse, with any abnormalities triggering imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be adults, aged 18 years and over with histologically confirmed, locally advanced HNSCC, who are HPV negative and considered of intermediate or high risk, and will be offered radical treatment. This includes surgery and any postoperative adjuvant/consolidation treatment, or radical chemo-radiation.
Key inclusion criteria (4 listed)
- Histologically confirmed, locally advanced HNSCC, HPV negative considered as intermediate or high risk .
- Offered radical treatment. (This includes surgery and any postoperative adjuvant/consolidation treatment, or radical chemo-radiation).
- Age ≥ 18 years.
- Adequate bone marrow function (nNeutrophils, platelets and haemoglobin grade 0 or 1 according to CTCAE).
Key exclusion criteria (6 listed)
- HPV positive disease.
- Participants with concurrent malignancy.
- Confirmed distant metastatic disease on most recent imaging scan.
- Known Hepatitis B, C or HIV infection .
- Contraindications to MRI (including but not limited to cardiac pacemaker, metallic implants, major claustrophobia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Was a multimodal signature developed to risk-stratify participants with locally advanced radically treated head and neck cancer?
Time frame: 4 years (data collection period)
Yes or No
1 secondary outcome
Was a non-invasive method of surveillance successfully developed?
Time frame: 4 years (data collection period)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Derived from this study: PubMed 42785937Mithra S, Ahmed AA, Roshan A, Barber PR, de Carvalho Gomes C, Coolen T, Sawyer E, Rosenfeld N, Sinkus R, Reis-Ferreira M, Connor S, Shmueli K, Morley S, Nenclares P, Apsey C, Hackshaw A, Arora A, Beeston T, Tuazon J, Berin M, Yeung A, Curtis C, Ng K, Mustapha R, Gillett C, Issa B, Brew-Graves C, Lioumi M, Ng T, Forster M. Multimodality detection of early relapse in radically treated high-risk HPV-negative head and neck squamous cell carcinoma: study protocol for a prospective multicentre UK cohort study (HERD). BMJ Open. 2026 Sep 24;16(9):e121924. doi: 10.1136/bmjopen-2026-121924.
- 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.
Martin Forster, Dr principal investigator
University College, London
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 Cancer, run by University College, London 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 6 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 5 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trial Manager (02076709274, NCITA.HERD@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Was a multimodal signature developed to risk-stratify participants with locally advanced radically treated head and neck cancer? (time frame: 4 years (data collection period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05097625, which also lists 1 linked publication.
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 5 Oct 2023.