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

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.

Conditions

• Ovarian Cancer

Interventions

OTHER

Intervention 1

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.

OTHER

Intervention 2

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

Sponsors & Collaborators

• The University of Queensland

  collaborator OTHER

• Mater Medical Research Institute

  collaborator OTHER

• Lions Medical Research Foundation

  collaborator UNKNOWN

• UQ Centre for Extracellular Vesicle Nanomedicine

  collaborator UNKNOWN

• Australia Ovarian Cancer Research Foundation

  collaborator UNKNOWN

• Queensland Centre for Gynaecological Cancer

  lead OTHER_GOV

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Max Age

74 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2028-12-31

Completion

2030-12-31

Countries

• Australia

Study Locations