Clinical trial · Observational
The Role of Circulating Tumour DNA in Head and Neck Cancer
- 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)
Cancers of the throat, oropharyngeal squamous cell carcinoma (OPSCC), are highly prevalent across Scotland. Over the past 10 years, both global and Scottish cases of OPSCC have increased, particularly those associated with human papillomavirus (HPV). However there has been little change in techniques for diagnosis and monitoring. Although imaging technologies are improving, results of imaging are often indeterminate and clinicians require additional tools to make informed decisions. With this in mind our research team have established a range of blood- based tests which detect and monitor cancer DNA fragments shed by tumours into the blood stream in OPSCC patients. Our initial studies have shown that such tests, which are minimally invasive compared to surgical biopsy, hold the potential to provide an accurate, "real-time" method to monitor patient response to treatment, identify early relapse and assist in clinical decision making. The investigators aim to expand these results to assist clinical decisions for both virally associated and non-viral associated OPSCC. Following this, the investigators will focus on the poorest prognosis OPSCC group (non-HPV tumours) by applying state-of-the-art DNA detection and sequencing technologies to analyse tumour- derived DNA fragments in the bloodstream, to follow treatment response and to develop new methods for detecting relapse and resistance to treatment in OPSCC. Ultimately, the investigators envisage that the implementation of such genetic assays of tumours and the fragments that they release into the bloodstream will provide a transformative shift in the clinical assessment and quality of life of OPSCC patients in Scotland.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus (HPV) | — | UNRESOLVED | — |
| Oropharyngeal Squamous Cell Carcinoma | Oropharyngeal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Longitudinal monitoring of HPV+ve tumour burden through analysis of HPV cfDNA by ddPCR to assess treatment success and for early detection of relapse.
- timeFrame
- 3 years
- description
- A sample of blood (approx. 20 ml) will be collected from each participant. Using ddPCR assays the blood samples will be analysed for the 5 most prevalent serotypes of HPV seen in OPSCC (HPV16, 18, 31, 33 \& 35) allowing for the quantification of cfDNA present in the blood samples (HPV copies/ml). This will be repeated longitudinally at several time points to correlate HPV DNA levels (HPV copies/ml) with the standard of care (12 week post treatment imaging, salvage surgery and biopsy where indicated, and clinical follow up) and to formally measure assay predictive value.
Secondary outcomes (1)
- measure
- The determination of tumour burden in HPV-ve OPSCC biopsy's
- timeFrame
- 3 years
- description
- The investigators aim to define the genomic aberrations present in each HPV-ve patient's tumour biopsy material by Whole Exome Sequencing (WES) of solid tumour biopsied or resected at presentation. Genomic DNA will be isolated from tumour DNA taken from tissue biopsy material using commercially available exome sequencing kits and DNA libraries prepared prior to sequencing at our local sequencing facility on an Illumina Nextseq, at a target coverage of 100X.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with oropharyngeal squamous cell carcinoma * Both HPV positive and negative disease Exclusion Criteria: * Patients under 18 years of age * Those who lack capacity to consent * Patients with non-squamous cell carcinoma * Patients with squamous cell carcinoma out with the oropharynx
References
Publications (0)
Data not yet available