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

NCT07491081 | Recruiting

• 1 other identifier: Early Study
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 2

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. 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. 2.Evaluating the stability of collected and transported blood samples and isolated extracellular vesicles during shipment and storage.

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer Detection; Ovarian Cancer; Ovarian Cancer Screening; Ovarian Cancer Blood Test; Extracellular Vesicles

Outcome Measures

Primary Outcomes (5)

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

  5 years

• Proportion of eligible participants who provide informed consent to participate in the study among all individuals approached and assessed for eligibility (acceptability).

  5 years

• Effect of real-world sampling and processing methods on extracellular vesicle particle concentration (particles/mL) measured by nanoparticle tracking analysis (NTA) (quality).

  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 years

• Effect of real-world sampling and processing methods on EV size distribution (mean and mode, nm) measured by nanoparticle tracking analysis (NTA) (quality).

  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 years

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

  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 years

Study Arms (1)

Females aged between 50 and 74 years, postmenopausal, and based in Queensland.

OTHER

Blood samples will be collected from 1,500 eligible participants. Participants will undergo venous blood collection using a standardised protocol designed to support extracellular vesicle biomarker analysis. Blood samples and isolated extracellular vesicles will be subjected to predefined storage and transport conditions to evaluate biomarker stability.

Other: Intervention 1; Other: Intervention 2

Interventions

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.

Females aged between 50 and 74 years, postmenopausal, and based in Queensland.

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

Females aged between 50 and 74 years, postmenopausal, and based in Queensland.

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 50 and 74 years (inclusive).
• Postmenopausal status, defined as either:
• 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.

You may not qualify if:

• History of previous ovarian malignancy.
• History of bilateral oophorectomy.

Sponsors & Collaborators

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

Study Sites (2)

Mater Misericordiae Ltd

Brisbane, Queensland, Australia

RECRUITING

The University of Queensland

Brisbane, Queensland, Australia

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Sara Baniahmadi

CONTACT

+61 7 3346 5073; s.baniahmadi@uq.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: March 24, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)