EARLY Biomarker Panel for Ovarian Cancer Detection
EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection
NA · Queensland Centre for Gynaecological Cancer · NCT07491081
This project will test whether different blood collection, storage, and transport methods keep ovarian cancer extracellular vesicle biomarkers stable in postmenopausal people aged 50–74.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 50 Years to 74 Years |
| Sex | Female |
| Sponsor | Queensland Centre for Gynaecological Cancer (other gov) |
| Locations | 2 sites (Brisbane, Queensland and 1 other locations) |
| Trial ID | NCT07491081 on ClinicalTrials.gov |
What this trial studies
This prospective study will recruit 1,500 postmenopausal participants across Queensland through community groups and the Mater Research Biobank with informed consent. Blood samples will be collected using predefined protocols and processed at collaborating laboratory sites to isolate extracellular vesicles (EVs). The study will systematically vary collection protocols, storage temperatures, transport conditions, and time-to-processing to measure EV biomarker stability. Findings will be used to recommend practical sample-handling procedures for future blood-based ovarian cancer screening efforts.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal people aged 50–74 without a history of ovarian cancer or bilateral oophorectomy who can provide informed consent and attend a Brisbane collection site.
Not a fit: People with prior ovarian malignancy, a prior bilateral oophorectomy, those outside the 50–74 age range, or those unable to attend the Queensland collection sites are not eligible and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the work could make blood-based ovarian cancer screening more reliable by identifying best practices for sample collection and handling.
How similar studies have performed: Research on extracellular vesicle biomarkers for ovarian cancer is promising but remains largely experimental and has not yet produced widely adopted clinical screening tests.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Brisbane, Queensland and 1 other locations
- Mater Misericordiae Ltd — Brisbane, Queensland, Australia (RECRUITING)
- The University of Queensland — Brisbane, Queensland, Australia (RECRUITING)
Study contacts
- Study coordinator: Sara Baniahmadi
- Email: s.baniahmadi@uq.edu.au
- Phone: +61 7 3346 5073
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ovarian Cancer, Ovarian Cancer Detection, Ovarian Cancer Screening, Ovarian Cancer Blood Test, Extracellular Vesicles