Intervention 1: Approximately 30 mL of peripheral venous blood will be collected from each participant using validated blood collection tubes. Samples will be processed according to predefined standard operating procedures, including controlled storage temperatures and defined time-to-processing conditions.
Intervention 2: Collected blood samples and derived extracellular vesicles will be exposed to different pre-analytical conditions including:
* Variation in storage temperatures
* Variation in transport conditions
* Variation in time from collection to processing
* Evaluation of extracellular vesicle stability during shipment and storage
Study summary
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:
1. 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.
2. 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.
Eligibility
Sex
FEMALE
Min age
50 Years
Max age
74 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Age between 50 and 74 years (inclusive).
2. Postmenopausal status, defined as either:
2.1. At least 12 consecutive months of amenorrhoea following natural menopause or hysterectomy, or 2.2. At least 12 months of hormone replacement therapy (HRT) commenced for the management of menopausal symptoms.
3. Signed written informed consent.
Exclusion Criteria:
1. History of previous ovarian malignancy.
2. History of bilateral oophorectomy.
Primary outcome measure(s)
Proportion of participants with successful blood collection and extracellular vesicle extraction according to the study protocol (feasibility). — 5 years
Proportion of eligible participants who provide informed consent to participate in the study among all individuals approached and assessed for eligibility (acceptability). — 5 years
Effect of real-world sampling and processing methods on extracellular vesicle particle concentration (particles/mL) measured by nanoparticle tracking analysis (NTA) (quality). — 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). — 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). — 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.
Trial sites (2)
Facility
City
Region
Status
Mater Misericordiae Ltd
Brisbane
Queensland
Recruiting
The University of Queensland
Brisbane
Queensland
Recruiting
More Queensland Centre for Gynaecological Cancer trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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