NCT07491081 EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection
| NCT ID | NCT07491081 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Queensland Centre for Gynaecological Cancer |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,500 participants in total. It began in 2026-02-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07491081 clinical trial?
This trial is open to female participants only, aged 50 Years or older, up to 74 Years, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07491081 currently recruiting?
Yes, NCT07491081 is actively recruiting participants. Contact the research team at s.baniahmadi@uq.edu.au for enrollment information.
Where is the NCT07491081 trial being conducted?
This trial is being conducted at Brisbane, Australia, Brisbane, Australia.
Who is sponsoring the NCT07491081 clinical trial?
NCT07491081 is sponsored by Queensland Centre for Gynaecological Cancer. The trial plans to enroll 1,500 participants.
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