Ovarian CancerNCT07491081
EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection
A study testing Intervention 1 and Intervention 2 in people with Ovarian Cancer, run by Queensland Centre for Gynaecological Cancer at 2 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Intervention 1 and Intervention 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 2 sitesAustralia
- Study dates
- 1 Feb 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of previous ovarian malignancy.
- History of bilateral oophorectomy.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Mater Misericordiae Ltd
Brisbane, Queensland
Kaltin Ferguson, kaltin.ferguson@mater.org.au
John Hooper, Professor
- Recruiting
The University of Queensland
Brisbane, Queensland
Sara Baniahmadi, +61 7 3346 5073, s.baniahmadi@uq.edu.au
Carlos Salomon, Professor
About this study
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:
Read more
- 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.
- 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
- Being tested
- Intervention 1, Intervention 2
- Keywords
- Ovarian Cancer Detection, Ovarian Cancer, Ovarian Cancer Screening, Ovarian Cancer Blood Test, Extracellular Vesicles
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1Other
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 2Other
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intervention 1; Other: Intervention 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with successful blood collection and extracellular vesicle extraction according to the study protocol (feasibility).
Measured: 5 years
Proportion of eligible participants who provide informed consent to participate in the study among all individuals approached and assessed for eligibility (acceptability).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queensland Centre for Gynaecological Cancer
- Sponsor type
- Other government
- Collaborators
- The University of Queensland, Mater Medical Research Institute, Lions Medical Research Foundation, UQ Centre for Extracellular Vesicle Nanomedicine, Australia Ovarian Cancer Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491081
- Sponsor's protocol ID
- Early Study
- Status last verified
- Mar 2026
- First submitted
- 18 Feb 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection
- ClinicalTrials.gov ID
- NCT07491081
- Acronym / sponsor ID
- Early Study
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer Detection, Ovarian Cancer, Ovarian Cancer Screening, Ovarian Cancer Blood Test, Extracellular Vesicles
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Queensland Centre for Gynaecological CancerOther government
- Collaborators
- The University of Queensland, Mater Medical Research Institute, Lions Medical Research Foundation, UQ Centre for Extracellular Vesicle Nanomedicine, Australia Ovarian Cancer Research Foundation
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Females aged between 50 and 74 years, postmenopausal, and based in Queensland. | Other | Other: Intervention 1, Other: Intervention 2Blood 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. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- History of previous ovarian malignancy.
- History of bilateral oophorectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention 1Approximately 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 | Females aged between 50 and 74 years, postmenopausal, and based in Queensland. |
| Intervention 2Collected 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 | Other | Females aged between 50 and 74 years, postmenopausal, and based in Queensland. |
Primary outcome
Proportion of participants with successful blood collection and extracellular vesicle extraction according to the study protocol (feasibility).
Time frame: 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
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1 and Intervention 2 in people with Ovarian Cancer, run by Queensland Centre for Gynaecological Cancer at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Baniahmadi (+61 7 3346 5073, s.baniahmadi@uq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with successful blood collection and extracellular vesicle extraction according to the study protocol (feasibility). (time frame: 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.