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

March 19, 2026 updated by: Queensland Centre for Gynaecological Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia
        • Recruiting
        • Mater Misericordiae Ltd
        • Contact:
        • Principal Investigator:
          • John Hooper, Professor
      • Brisbane, Queensland, Australia
        • Recruiting
        • The University of Queensland
        • Contact:
        • Principal Investigator:
          • Carlos Salomon, Professor
        • Principal Investigator:
          • Andreas Obermair, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Females aged between 50 and 74 years, postmenopausal, and based in Queensland.

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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of participants with successful blood collection and extracellular vesicle extraction according to the study protocol (feasibility).
Time Frame: 5 years
5 years
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
5 years
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.
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).
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 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Queensland Centre for Gynaecological Cancer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The University of Queensland
Mater Medical Research Institute
Lions Medical Research Foundation
UQ Centre for Extracellular Vesicle Nanomedicine
Australia Ovarian Cancer Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Early Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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