Clinical trial · Observational
Head and Neck Early Relapse Detection Study (HERD)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- High Risk Pathway
- description
- 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
- label
- Low Risk Pathway
- description
- 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
Primary outcomes (1)
- measure
- Was a multimodal signature developed to risk-stratify participants with locally advanced radically treated head and neck cancer?
- timeFrame
- 4 years (data collection period)
- description
- Yes or No
Secondary outcomes (1)
- measure
- Was a non-invasive method of surveillance successfully developed?
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed, locally advanced HNSCC, HPV negative considered as intermediate or high risk . 2. Offered radical treatment. (This includes surgery and any postoperative adjuvant/consolidation treatment, or radical chemo-radiation). 3. Age ≥ 18 years. 4. Adequate bone marrow function (nNeutrophils, platelets and haemoglobin grade 0 or 1 according to CTCAE). Exclusion Criteria: 1. HPV positive disease. 2. Participants with concurrent malignancy. 3. Confirmed distant metastatic disease on most recent imaging scan. 4. Known Hepatitis B, C or HIV infection . 5. Contraindications to MRI (including but not limited to cardiac pacemaker, metallic implants, major claustrophobia). 6. Pregnant and lactating patients.
References
Publications (0)
Data not yet available