None listed
Conditions
Brief summary
Study purpose: This study aims to find out whether tumour signals in blood and saliva such as tumour-related DNA and cells, can give early information about how well treatment is working and whether the cancer is returning. Who is it for: People aged between 18 and 100 years who have recently been diagnosed with p16-positive oropharyngeal cancer and are about to start curative radiotherapy, with or without chemotherapy. Study details: Participants will give blood and saliva samples at several time points — before treatment, during treatment (around 4 weeks), and after treatment (at 13 weeks, 1 year, and 2 years). The samples will be tested for three types of “liquid biopsy” markers: • Human papillomavirus (HPV) DNA found in saliva • Circulating tumour cells (CTCs) found in the blood • Circulating tumour DNA (ctDNA), small pieces of cancer DNA in the blood The study will track how these markers change over time and compare them with scan results and clinical outcomes. The goal is to find an easier, less invasive way to monitor patients and detect cancer returning earlier than with standard methods. Contribution to the field: It is hoped that the findings will support the development of minimally invasive tools for personalised disease monitoring and earlier detection of recurrence in oropharyngeal cancer.
Interventions
This is a longitudinal, prospective observational study involving 100 participants with p16-positive oropharyngeal squamous cell carcinoma (OPSCC). Blood and saliva samples are collected from the patients at defined time points — baseline (pre-treatment), 4 weeks during treatment, 13 weeks, 1 year, and 2 years post-treatment — to evaluate three complementary liquid biopsy biomarkers:
Salivary hrHPV DNA quantified by multiplex PCR for HPV-16, -18, -31, -33. Circulating tumour cells (CTCs) and CT
This is a longitudinal, prospective observational study involving 100 participants with p16-positive oropharyngeal squamous cell carcinoma (OPSCC). Blood and saliva samples are collected from the patients at defined time points — baseline (pre-treatment), 4 weeks during treatment, 13 weeks, 1 year, and 2 years post-treatment — to evaluate three complementary liquid biopsy biomarkers: Salivary hrHPV DNA quantified by multiplex PCR for HPV-16, -18, -31, -33. Circulating tumour cells (CTCs) and CTC clusters captured using a spiral microfluidic chip and characterised by immunofluorescence. Circulating tumour DNA (ctDNA) mutation profiling using a targeted hybrid-capture next-generation sequencing panel. The exposure being studied is the presence and dynamics of these biomarkers, and the outcomes include their correlation with treatment response, recurrence, and survival.
Sponsors
Griffith University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
• Adults aged between 18 and 100 years, inclusive • Newly Diagnosed with oropharyngeal SCC with p16 positive pathology and treatment naïve (only surgical biopsy is allowed) • Planned curative intent radiotherapy with or without chemotherapy • Life expectancy of greater than 6 months • Patients are able to give informed consent
Exclusion criteria
• Definitive surgical resection of either primary or nodal disease • Current illness that will interfere with the collection of saliva and/or blood samples, e.g. Sjogren’s Syndrome • High risk of poor compliance with study requirements or follow-up visits • Previous Radiotherapy to the head and neck within the last 5 years • Previous chemotherapy within the last 5 years • Other cancers that were diagnosed within 5 years of the current diagnosis, except successfully treated BCC or SCC (skin) carcinoma, in situ melanoma, or carcinoma in situ of the cervix.
Outcome results
None listed