NCT07491081Recruiting
EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection
Source: ClinicalTrials.gov · Last updated 24 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1500 (estimated)
- First submitted
- 18 Feb 2026
- Start date
- 1 Feb 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Queensland Centre for Gynaecological Cancer
- Diseases
- Ovarian cancer
- NCT number
- NCT07491081
What you commit to
- Study type: Interventional
- Planned participants: 1500
- From 1 Feb 2026 to the primary completion date, 31 Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous ovarian malignancy.
Other illness
- History of bilateral oophorectomy.
Who the study is looking for
- 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.
Age in the registry: 50 years to 74 years · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mater Misericordiae Ltd. Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| The University of Queensland Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.