Clinical trial Recruiting at 2 sites Interventional Ages 50 to 74 Women only

EARLY Biomarker Panel for Ovarian Cancer Detection

Official title: EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection

Run by Queensland Centre for Gynaecological Cancer · NCT07491081 · Data updated 2026-11-12

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

Study typeInterventional
Ages50 Years to 74 Years
SexWomen only
Enrollment1500 (estimated)
SponsorQueensland Centre for Gynaecological Cancer
Government
Locations2 sites (Brisbane, Queensland and 1 other locations)
StatusRecruiting
StartedFebruary 1, 2026
Main results expectedDecember 31, 2028
Study endsDecember 31, 2030
Registry record updatedMarch 24, 2026
Trial IDNCT07491081 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Research on extracellular vesicle biomarkers for ovarian cancer is promising but remains largely experimental and has not yet produced widely adopted clinical screening tests.

Who can join: the full rules

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 it's running

  • Mater Misericordiae Ltd
    Brisbane, Queensland, Australia
    Recruiting
  • The University of Queensland
    Brisbane, Queensland, Australia
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.