Blood-based lipidomic biomarker signature for breast cancer detection in wome
Not Applicable
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2023/12/060521
- Lead Sponsor
- BCAL Diagnostics Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
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.
Exclusion Criteria
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: Baseline only
- Secondary Outcome Measures
Name Time Method •Evidence for (or against) the collection, processing, storage & transport of samples from India into Australia for lipidomic testing and analysisTimepoint: single blood collection at baseline