A pilot study evaluating the feasibility of BCAL’s blood-based lipidomic biomarker signature for breast cancer detection in women.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 291
- 试验地点
- 2
- 主要终点
- Verification that the diagnostic performance of BCAL’s lipidomic biomarker signature using mass spectrometry, for the detection of breast cancer in fasted plasma collected from women 30 years of age is comparable to previous study performance.
研究概览
简要总结
BCAL’s previous studies showed that the BCAL lipid signature assessed initially from plasma extracellular vesicles, and in the latest study directly from plasma could potentially effectively distinguish breast cancer cases from negative and positive controls (healthy and benign respectively). We are undertaking this study to confirm test performance across different racial and ethnically diverse populations. We are also evaluating the feasibility for having samples collected, processed, stored in India following established SOPs and transported to BCAL’s R&D facility in Australia for testing and analysis. The pilot is to ensure specimen integrity is upheld as a lead into larger-scale clinical validation studies.
We hypothesise that the BCAL breast cancer lipid signature accuracy (sensitivity and specificity) in detecting breast cancer from fasted plasma in AFAB women from India performs as expected and there is minimal to no impact on specimen integrity, should samples be tested and analysed from Australia.
This study is a multi-center,prospective cohort study involving a single-point collection of whole bloodspecimens by venepuncture with associated data, under informed consent fortesting and analysis at BCAL’s R&D facility in Sydney, Australia.
PRIMARYOBJECTIVES
· Todetermine the accuracy (specificity and sensitivity) of the BCAL breast cancerlipid biomarker signature for the detection of breast cancer in women fromIndia, >30 years of age, with and without breast cancer.
SECONDARYOBJECTIVES
· Toassess biospecimen integrity following collection, processing, and temporarystorage and transport from India to Australia for lipidomic testing.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Female
入选标准
- •Able and willing to provide informed consent  Women assigned female at birth (AFAB)  Aged 30 years or older Treatment naïve Not on any hormone replacement therapy Diagnosed with primary breast cancer, with no previous history of known cancer OR recently confirmed (radiological/pathological) benign breast lump with no previous history of known cancer OR no current or previous history of known cancer.
排除标准
- •Pregnant or breast feeding Any acute or chronic condition that would limit the ability of the patient to participate in the study Previous (or current) chemotherapy or radiotherapy treatment Currently on hormone replacement therapy Refusal to provide informed consent Previous history of cancer.
结局指标
主要结局
Verification that the diagnostic performance of BCAL’s lipidomic biomarker signature using mass spectrometry, for the detection of breast cancer in fasted plasma collected from women 30 years of age is comparable to previous study performance.
时间窗: Baseline only
次要结局
- •Evidence for (or against) the collection, processing, storage & transport of samples from India into Australia for lipidomic testing and analysis(single blood collection at baseline)