NCT07796672Recruiting
Feasibility Study of Blood Biomarker Identification in Cervical Cancer
Feasibility Study of Blood Biomarker Identification in Cervical Cancer: Performance of Cell-free DNA Versus Extracellular Vesicles
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 27 Aug 2026
- Start date
- 15 Sept 2026
- Primary completion date
- 15 Sept 2030
- Lead sponsor
- Queensland Centre for Gynaecological Cancer
- Diseases
- Cervical cancer
- NCT number
- NCT07796672
What you commit to
- Study type: Observational
- Planned participants: 100
- From 15 Sept 2026 to the primary completion date, 15 Sept 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
Age
- Prior malignancies \<5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma in situ.
Other
- Unable to provide informed consent
Who the study is looking for
- Females, over 18 years, with histologically confirmed squamous cell carcinoma or adenocarcinoma of the cervix (stage 1a to 4b)
- Undergo intensive primary surgical treatment, radiotherapy (RT) or chemoradiotherapy (CRT).
- Signed written informed consent
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Brisbane and Women's Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.