EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- Proportion of participants with successful blood collection and extracellular vesicle extraction according to the study protocol (feasibility).
研究概览
简要总结
The overall aim of the EARLY study is to systematically evaluate the impact of blood collection protocols, storage temperatures, transport conditions, and time to processing on the stability of extracellular vesicle (EV) biomarkers associated with ovarian cancer, with the potential to inform and improve future ovarian cancer screening practices.
This prospective study will inform future screening studies by:
- Assessing the feasibility of participant recruitment and blood sample collection for extracellular vesicle analysis in a real-world healthcare setting, including evaluation of the practicality and effectiveness of these processes.
- Evaluating the stability of collected and transported blood samples and isolated extracellular vesicles during shipment and storage.
A total of 1,500 participants will be recruited through community groups across Queensland, Australia, in collaboration with the Mater Research Biobank. Eligible participants who provide informed consent will have approximately 30 mL of blood collected for extracellular vesicle analysis. Data will also be collected on demographics (e.g. age and ethnicity), lifestyle factors (e.g. smoking status), medical, surgical and gynaecological history, family history of cancer, date of last menstrual period, and use of hormone replacement therapy (HRT). Participation in the study will conclude after blood sample collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 50 and 74 years (inclusive).
- •Postmenopausal status, defined as either:
- •At least 12 consecutive months of amenorrhoea following natural menopause or hysterectomy, or 2.
- •At least 12 months of hormone replacement therapy (HRT) commenced for the management of menopausal symptoms.
- •Signed written informed consent.
排除标准
- •History of previous ovarian malignancy.
- •History of bilateral oophorectomy.
结局指标
主要结局
Proportion of participants with successful blood collection and extracellular vesicle extraction according to the study protocol (feasibility).
时间窗: 5 years
Proportion of eligible participants who provide informed consent to participate in the study among all individuals approached and assessed for eligibility (acceptability).
时间窗: 5 years
Effect of real-world sampling and processing methods on extracellular vesicle particle concentration (particles/mL) measured by nanoparticle tracking analysis (NTA) (quality).
时间窗: 5 years
Blood samples will be processed at pre-defined time intervals after collection (0-2 hours, 4-8 hours, ≥12 hours, ≥24 hours, and ≥36 hours) to evaluate the effect of real-world sampling, logistics, and processing delays. Results will be summarised using descriptive statistics (mean and standard deviation) and comparisons between processing-time groups to determine the robustness of the EV-based assay under real-world sampling conditions.
Effect of real-world sampling and processing methods on EV size distribution (mean and mode, nm) measured by nanoparticle tracking analysis (NTA) (quality).
时间窗: 5 years
Blood samples will be processed at pre-defined time intervals after collection (0-2 hours, 4-8 hours, ≥12 hours, ≥24 hours, and ≥36 hours) to evaluate the effect of real-world sampling, logistics, and processing delays. Results will be summarised using descriptive statistics (mean and standard deviation) and comparisons between processing-time groups to determine the robustness of the EV-based assay under real-world sampling conditions.
Effect of real-world sampling and processing methods on EV biomarker expression assessed using EV-associated protein markers (quality).
时间窗: 5 years
Blood samples will be processed at pre-defined time intervals after collection (0-2 hours, 4-8 hours, ≥12 hours, ≥24 hours, and ≥36 hours) to evaluate the effect of real-world sampling, logistics, and processing delays. Results will be summarised using descriptive statistics (mean and standard deviation) and comparisons between processing-time groups to determine the robustness of the EV-based assay under real-world sampling conditions.
次要结局
未报告次要终点