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| Name | Class |
|---|---|
| The University of Queensland | OTHER |
| Mater Medical Research Institute | OTHER |
| Lions Medical Research Foundation | UNKNOWN |
| UQ Centre for Extracellular Vesicle Nanomedicine |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Baniahmadi | Contact | +61 7 3346 5073 | s.baniahmadi@uq.edu.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mater Misericordiae Ltd | Recruiting | Brisbane | Queensland | Australia |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| UNKNOWN |
| Australia Ovarian Cancer Research Foundation | UNKNOWN |
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| Intervention 2 | Other | Collected blood samples and derived extracellular vesicles will be exposed to different pre-analytical conditions including:
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|
| 5 years |
| The University of Queensland | Recruiting | Brisbane | Queensland | Australia |
|
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |