NCT07796672 Feasibility Study of Blood Biomarker Identification in Cervical Cancer
| NCT ID | NCT07796672 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Queensland Centre for Gynaecological Cancer |
| Condition | Cervical Adenocarcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-09-15 |
| Primary Completion | 2030-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-09-15 with a primary completion date of 2030-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Unable to provide informed consent * Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) * Prior malignancies \<5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma in situ.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07796672 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cervical Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07796672 currently recruiting?
Yes, NCT07796672 is actively recruiting participants. Contact the research team at a.obermair@uq.edu.au for enrollment information.
Where is the NCT07796672 trial being conducted?
This trial is being conducted at Brisbane, Australia.
Who is sponsoring the NCT07796672 clinical trial?
NCT07796672 is sponsored by Queensland Centre for Gynaecological Cancer. The trial plans to enroll 100 participants.