RecruitingNCT05539638

The Role of Circulating Tumour DNA in Head and Neck Cancer


Sponsor

University of Edinburgh

Enrollment

250 participants

Start Date

Aug 14, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether a blood test that detects tumor DNA fragments (called circulating tumor DNA, or ctDNA) can help doctors monitor head and neck cancer more effectively — for example, to detect recurrence earlier or track how well treatment is working. Participants will have blood samples collected at various points in their treatment journey. **You may be eligible if:** - You have been diagnosed with squamous cell carcinoma of the oropharynx (back of the throat, including tonsils and base of tongue) - Your cancer is either HPV-positive or HPV-negative - You are 18 years or older and able to consent **You may NOT be eligible if:** - You are under 18 years old - You lack the capacity to consent - Your cancer is a non-squamous cell type (e.g., adenocarcinoma) - Your squamous cell cancer originates from outside the oropharynx Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(5)

Ninewells Hospital

Dundee, DD2 1SG, United Kingdom

Summerfield House - NHS Grampian

Aberdeen, United Kingdom

Monklands Hospital ENT

Airdrie, United Kingdom

The Royal Infirmiry

Edinburgh, United Kingdom

Glasgow Royal Infirmary

Glasgow, United Kingdom

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NCT05539638


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