Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07491081

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mater Misericordiae Ltd, Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention 1

Other

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.

Intervention 2

Other

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 outcomes

  1. Proportion of participants with successful blood collection and extracellular vesicle extraction according to the study protocol (feasibility).

    Time frame: 5 years

  2. 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

  3. 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

    Blood samples will be processed at pre-defined time intervals after collection (0-2 hours, 4-8 hours, ≥12 hours, ≥24 hours, and ≥36 hours) to evaluate the effect of real-world sampling, logistics, and processing delays. Results will be summarised using descriptive statistics (mean and standard deviation) and comparisons between processing-time groups to determine the robustness of the EV-based assay under real-world sampling conditions.

  4. 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

    Blood samples will be processed at pre-defined time intervals after collection (0-2 hours, 4-8 hours, ≥12 hours, ≥24 hours, and ≥36 hours) to evaluate the effect of real-world sampling, logistics, and processing delays. Results will be summarised using descriptive statistics (mean and standard deviation) and comparisons between processing-time groups to determine the robustness of the EV-based assay under real-world sampling conditions.

  5. Effect of real-world sampling and processing methods on EV biomarker expression assessed using EV-associated protein markers (quality).

    Time frame: 5 years

    Blood samples will be processed at pre-defined time intervals after collection (0-2 hours, 4-8 hours, ≥12 hours, ≥24 hours, and ≥36 hours) to evaluate the effect of real-world sampling, logistics, and processing delays. Results will be summarised using descriptive statistics (mean and standard deviation) and comparisons between processing-time groups to determine the robustness of the EV-based assay under real-world sampling conditions.

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Baniahmadi

CONTACT

[email protected]

+61 7 3346 5073

Sponsors and collaborators

Lead sponsor

Queensland Centre for Gynaecological Cancer

Other Gov

Collaborators

  • Australia Ovarian Cancer Research Foundation
  • Lions Medical Research Foundation
  • Mater Medical Research Institute
  • The University of Queensland
  • UQ Centre for Extracellular Vesicle Nanomedicine

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.