Feasibility Study of Blood Biomarker Identification in Cervical Cancer: Performance of Cell-free DNA Versus Extracellular Vesicles
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of participants with successful blood collection and analysable cfDNA and EVs
研究概览
简要总结
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.
详细描述
This study is an open-label, prospective, experimental study of patients with cervical cancer. The primary aim is to evaluate the feasibility, clinical utility, and analytical performance of extracellular vesicles (EVs) and cell-free DNA (cfDNA) as minimally invasive, blood-based biomarkers for the early detection, treatment monitoring, and post-treatment surveillance of cervical cancer, with the potential to inform future screening and therapeutic strategies.
Cervical cancer continues to impose significant physical, emotional, and financial burdens on women worldwide. Despite advances in prevention and treatment, a critical need remains 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, interest is growing in the use of blood-based biomarkers, particularly extracellular vesicles (EVs) and cell-free DNA (cfDNA), to improve patient care.
This study aims to evaluate the potential of EVs and cfDNA as minimally invasive biomarkers in the management of cervical cancer. Analysis of EVs and cfDNA is intended to provide deeper insights into the roles of these biomarkers 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. The study is intended to contribute to the development of a novel, blood-based screening and monitoring tool that could enable earlier intervention and improve long-term outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Patients with Cervical Cancer
Patients with FIGO stage IA-IVB cervical cancer undergoing standard-of-care primary surgery, radiotherapy, or chemoradiotherapy. Treatment is determined by the participant's treating clinical team and is not assigned by the study protocol. Participants will undergo serial blood collection for cfDNA and extracellular vesicle analyses, complete patient-reported outcome and quality-of-life questionnaires, and have disease status assessed through medical record review. Archival tumour tissue obtained during routine diagnostic biopsy or surgery will also be retrieved where available for translational analyses.
干预措施: Blood Sample Collection (Procedure)
Patients with Cervical Cancer
Patients with FIGO stage IA-IVB cervical cancer undergoing standard-of-care primary surgery, radiotherapy, or chemoradiotherapy. Treatment is determined by the participant's treating clinical team and is not assigned by the study protocol. Participants will undergo serial blood collection for cfDNA and extracellular vesicle analyses, complete patient-reported outcome and quality-of-life questionnaires, and have disease status assessed through medical record review. Archival tumour tissue obtained during routine diagnostic biopsy or surgery will also be retrieved where available for translational analyses.
干预措施: cfDNA and Extracellular Vesicle Biomarker Analysis (Other)
Patients with Cervical Cancer
Patients with FIGO stage IA-IVB cervical cancer undergoing standard-of-care primary surgery, radiotherapy, or chemoradiotherapy. Treatment is determined by the participant's treating clinical team and is not assigned by the study protocol. Participants will undergo serial blood collection for cfDNA and extracellular vesicle analyses, complete patient-reported outcome and quality-of-life questionnaires, and have disease status assessed through medical record review. Archival tumour tissue obtained during routine diagnostic biopsy or surgery will also be retrieved where available for translational analyses.
干预措施: Patient-Reported Outcome and Quality-of-Life Assessment (Other)
Patients with Cervical Cancer
Patients with FIGO stage IA-IVB cervical cancer undergoing standard-of-care primary surgery, radiotherapy, or chemoradiotherapy. Treatment is determined by the participant's treating clinical team and is not assigned by the study protocol. Participants will undergo serial blood collection for cfDNA and extracellular vesicle analyses, complete patient-reported outcome and quality-of-life questionnaires, and have disease status assessed through medical record review. Archival tumour tissue obtained during routine diagnostic biopsy or surgery will also be retrieved where available for translational analyses.
干预措施: Tumour Tissue Biomarker Analysis (Other)
结局指标
主要结局
Proportion of participants with successful blood collection and analysable cfDNA and EVs
时间窗: 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.
次要结局
- Proportion of eligible patients who consent to participate(At study screening/enrolment.)
- Proportion of cfDNA samples meeting prespecified analytical quality criteria(Baseline; approximately 8 weeks (±14 days) after surgery or within 14 days following completion of radiotherapy/chemoradiotherapy; and 6 months (±14 days) post-baseline.)
- Proportion of extracellular vesicle samples meeting prespecified analytical quality criteria(Baseline; approximately 8 weeks (±14 days) after surgery or within 14 days following completion of radiotherapy/chemoradiotherapy; and 6 months (±14 days) post-baseline.)
- Association between baseline cfDNA profiles and cervical cancer stage(Baseline)
- Association between baseline extracellular vesicle profiles and cervical cancer stage(Baseline)
- Association between changes in cfDNA biomarkers and response to radiotherapy or chemoradiotherapy(From baseline to the post-treatment assessment, within 14 days following completion of radiotherapy or chemoradiotherapy.)
- Association between changes in extracellular vesicle biomarkers and response to radiotherapy or chemoradiotherapy(From baseline to the post-treatment assessment, within 14 days following completion of radiotherapy or chemoradiotherapy.)
- Association between cfDNA and EV biomarkers and 24-month disease outcome(From baseline through 24 months (±30 days).)
- Completion rate of patient-reported outcome and quality-of-life questionnaires(Baseline; approximately 8 weeks (±14 days) after surgery or within 14 days following completion of radiotherapy/chemoradiotherapy; and 6 months (±14 days) post-baseline.)