NCT05539638 The Role of Circulating Tumour DNA in Head and Neck Cancer
| NCT ID | NCT05539638 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Edinburgh |
| Condition | Oropharyngeal Squamous Cell Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2022-08-14 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2022-08-14 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Ashley Tay
PRINCIPAL INVESTIGATOR
NHS Lothian
Frequently Asked Questions
Who can join the NCT05539638 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oropharyngeal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05539638 currently recruiting?
Yes, NCT05539638 is actively recruiting participants. Contact the research team at Iain.Nixon@nhslothian.scot.nhs.uk for enrollment information.
Where is the NCT05539638 trial being conducted?
This trial is being conducted at Dundee, United Kingdom, Aberdeen, United Kingdom, Airdrie, United Kingdom, Edinburgh, United Kingdom and 1 additional location.
Who is sponsoring the NCT05539638 clinical trial?
NCT05539638 is sponsored by University of Edinburgh. The principal investigator is Ashley Tay at NHS Lothian. The trial plans to enroll 250 participants.