CLARITY Study

Cervical cancer continues to impose significant physical, emotional, and financial burdens on women worldwide. Despite advances in prevention and treatment, there remains a critical need for more effective, non-invasive tools to support early detection, monitor treatment response, and guide clinical decision-making. As the field of cervical cancer diagnosis evolves, there is growing interest in the use of blood-based biomarkers, particularly extracellular vesicles (EVs) and cell-free DNA (cfDNA), for improving patient care.

This study aims to evaluate the potential of EVs and cfDNA as minimally invasive biomarkers in the management of cervical cancer. By analysing EVs and cfDNA, we seek to gain deeper insights into their roles in tumour development, progression, and intercellular communication. The anticipated outcomes include the identification of EV- and cfDNA-based signatures that can:

• Facilitate earlier detection of cervical cancer
• Enable real-time monitoring of treatment response
• Predict recurrence and disease progression
• Support the development of personalised therapeutic strategies

By generating preliminary comparative data on the diagnostic accuracy of EVs and cfDNA, this study will provide a critical foundation for future large-scale investigations. It aims to contribute to the development of a novel, blood-based screening and monitoring tool that could enable earlier intervention and improve long-term outcomes.

A reliable, non-invasive test would also serve as a more accessible and acceptable alternative to current cervical screening methods, particularly for women who face cultural, systemic, or personal barriers to participation. This is especially important for under-screened populations, including Aboriginal and Torres Strait Islander women and culturally diverse communities.

Ultimately, this research is expected to advance our understanding of the biological role of EVs and cfDNA in cervical cancer pathogenesis and progression. It supports the development of clinically effective, personalised diagnostic tools that improve outcomes, reduce healthcare costs, and contribute to Australia’s national strategy to eliminate cervical cancer as a public health issue while addressing persistent inequities in access to care.