EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention 1, Intervention 2.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer. Basic parameters: 50 years — 74 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other 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. - Other 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
Primary outcome measures
- Proportion of participants with successful blood collection and extracellular vesicle extraction according to the study protocol (feasibility). [Time frame: 5 years]
- Proportion of eligible participants who provide informed consent to participate in the study among all individuals approached and assessed for eligibility (acceptability). [Time frame: 5 years]
- Effect of real-world sampling and processing methods on extracellular vesicle particle concentration (particles/mL) measured by nanoparticle tracking analysis (NTA) (quality). [Time frame: 5 years]
- Effect of real-world sampling and processing methods on EV size distribution (mean and mode, nm) measured by nanoparticle tracking analysis (NTA) (quality). [Time frame: 5 years]
- Effect of real-world sampling and processing methods on EV biomarker expression assessed using EV-associated protein markers (quality). [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Age between 50 and 74 years (inclusive).
- 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.
- Signed written informed consent.
Exclusion criteria
- History of previous ovarian malignancy.
- History of bilateral oophorectomy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Australia · 2 centers
- Mater Misericordiae Ltd — Brisbane
- The University of Queensland — Brisbane
Identifiers
NCT: NCT07491081 · Early Study