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

Queensland Centre for Gynaecological Cancer

Status: Enrolling

Conditions: Ovarian Cancer

Treatments: Other: Intervention 2; Other: Intervention 1

Study type: Interventional

Funder types: Other

Identifiers

NCT07491081

Early Study

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: Female

Ages: 50 to 74 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,500 participants in 1 patient group

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

Other group

Description:

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.

Treatment:

Other: Intervention 1

Other: Intervention 2