The Role of Circulating Tumour DNA in Head and Neck Cancer

NCT05539638 | Recruiting

• 1 other identifier: AC21058
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 5

Brief Summary

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

Oropharyngeal Squamous Cell Carcinoma; Human Papillomavirus (HPV)

Outcome Measures

Primary Outcomes (1)

• Longitudinal monitoring of HPV+ve tumour burden through analysis of HPV cfDNA by ddPCR to assess treatment success and for early detection of relapse.

  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.

  3 years

Secondary Outcomes (1)

• The determination of tumour burden in HPV-ve OPSCC biopsy's

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Number of participants/volunteers = 400 patients with oropharyngeal squamous cell carcinoma recruited over 3-4 sites then followed for a median of 3 years.

You may qualify if:

• Patients with oropharyngeal squamous cell carcinoma
• Both HPV positive and negative disease

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (5)

Ninewells Hospital

Dundee, DD2 1SG, DD2 1SG, United Kingdom

NOT YET RECRUITING

Summerfield House - NHS Grampian

Aberdeen, AB15 6RE, United Kingdom

NOT YET RECRUITING

Monklands Hospital ENT

Airdrie, United Kingdom

RECRUITING

The Royal Infirmiry

Edinburgh, United Kingdom

NOT YET RECRUITING

Glasgow Royal Infirmary

Glasgow, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Ashley Tay

  NHS Lothian

  PRINCIPAL INVESTIGATOR

• Catriona Douglas

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

• Robin Crosbie

  NHS Lanarkshire

  PRINCIPAL INVESTIGATOR

• Jaiganesh Manickavasagam

  NHS Tayside

  PRINCIPAL INVESTIGATOR

• Kim Ah-see

  NHS Grampian

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iain Nixon

CONTACT

07968498525; Iain.Nixon@nhslothian.scot.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 14, 2022
• Study Start: August 14, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

GB (5)