Feasibility Study of Blood Biomarker Identification in Cervical Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Blood Sample Collection: Approximately 40 mL of blood will be collected at baseline, approximately 8 weeks (±14 days) after surgery or within 14 days following completion of radiotherapy/chemoradiotherapy, and 6 months (±14 days) post-baseline. Blood samples will be processed for isolation and analysis of cell-free DNA (cfDNA), extracellular vesicles (EVs), and germline DNA.

cfDNA and Extracellular Vesicle Biomarker Analysis: Blood-derived cell-free DNA (cfDNA) and extracellular vesicles (EVs) will be isolated and characterised using prespecified laboratory methods. cfDNA will be quantified, quality assessed, and may undergo sequencing. EVs will be characterised using methods including nanoparticle tracking analysis, transmission electron microscopy, western blotting, proteomics, and miRNA sequencing. Biomarker profiles will be evaluated in relation to disease stage, treatment response, and disease outcomes.

Patient-Reported Outcome and Quality-of-Life Assessment: Participants will complete patient-reported outcome and quality-of-life questionnaires at baseline, approximately 8 weeks after surgery or completion of radiotherapy/chemoradiotherapy, and 6 months post-baseline. Assessments include the FACT-Cx, EQ-5D-5L, and self-reported lower-extremity lymphoedema questionnaires.

Tumour Tissue Biomarker Analysis: Formalin-fixed paraffin-embedded (FFPE) tumour tissue obtained during routine diagnostic biopsy or surgery will be retrieved from pathology laboratories where available. No research-specific tumour biopsy or surgery will be performed. Tumour tissue may undergo DNA extraction and sequencing for comparison with blood-derived DNA and other prespecified translational analyses.

Study summary

This study aims to explore whether a simple blood test can be used to help detect and monitor cervical cancer. The investigators are studying tiny fragments and particles found in blood, called cell-free DNA (cfDNA) and extracellular vesicles (EVs), to determine whether these can act as early warning signs (biomarkers) of cervical cancer.

Cell-free DNA (cfDNA) refers to tiny fragments of genetic material (DNA) that are naturally released from cells into the bloodstream when cells die or renew. Cell-free DNA circulates naturally in the blood. In people with cancer, some of the cfDNA originates from cancer cells; this component is called circulating tumour DNA (ctDNA). Analysis of cfDNA can detect signs of cancer, such as specific genetic changes or pieces of viral DNA, including human papillomavirus (HPV) DNA, without requiring removal of tissue from the cervix.

Extracellular vesicles (EVs) are very small "packages" released by cells into the blood and other body fluids. EVs carry messages between cells and contain important information such as proteins, fats, and genetic material, including RNA. In cancer, tumour cells release EVs that reflect tumour behaviour and activity. Analysis of EVs can provide information about cancer growth and response to treatment.

Together, cfDNA and EVs can act as tiny messengers or "fingerprints" of biological processes occurring inside the body. Analysis of cfDNA and EVs in blood samples may support the development of a simple, less invasive, more comfortable, and more accessible approach to detecting and monitoring cervical cancer compared with current screening and diagnostic methods. A blood test could also assist doctors in monitoring treatment response or detecting early signs of recurrence without requiring a surgical biopsy.

The expected outcomes of this study are to identify specific patterns or "signatures" in extracellular vesicles (EVs) and cell-free DNA (cfDNA) found in blood samples. These signatures could help to:

Detect cervical cancer earlier, before symptoms appear or the disease progresses.

Monitor treatment response in real time without the need for invasive tests. Predict whether cervical cancer might recur or spread after treatment. Support more personalised care by helping doctors select the most suitable treatment for each participant.

Eligibility

Primary outcome measure(s)

• Proportion of participants with successful blood collection and analysable cfDNA and EVs — Baseline; approximately 8 weeks (±14 days) after surgery or within 14 days following completion of radiotherapy/chemoradiotherapy; and 6 months (±14 days) post-baseline.
  Percentage of enrolled participants for whom blood is successfully collected and both cell-free DNA (cfDNA) and extracellular vesicles (EVs) are successfully isolated and meet prespecified laboratory quality-control criteria for the planned downstream analyses. Feasibility will be assessed at each of the three scheduled blood-collection time points.

Trial sites (1)

More Queensland Centre for Gynaecological Cancer trials in Australia

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