Detecting early relapses in head and neck cancer
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
This study is testing a new way to catch early signs of relapse in patients with advanced head and neck cancer using simple blood and saliva tests to help improve their chances of recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (London) |
| Trial ID | NCT05097625 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve early detection of relapses in patients with locally advanced head and neck squamous cell carcinoma (HNSCC) by developing a multimodal surveillance strategy. It will recruit 200 participants and utilize non-invasive methods, such as blood and saliva tests, to monitor for signs of relapse, triggering imaging when abnormalities are detected. The goal is to stratify patients into different surveillance pathways based on their risk profiles, ultimately facilitating timely salvage surgery and improving survival outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed, locally advanced HPV negative head and neck cancer who are receiving radical treatment.
Not a fit: Patients with HPV positive disease, concurrent malignancies, or confirmed distant metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance early relapse detection, leading to improved survival rates for patients with head and neck cancer.
How similar studies have performed: While the approach of using multimodal surveillance is innovative, similar studies have shown promise in improving early detection of cancer relapses.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
London
- Guy's and St Thomas' — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Martin Forster, Dr — University College, London
- Study coordinator: Trial Manager
- Email: NCITA.HERD@ucl.ac.uk
- Phone: 02076709274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.