Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
BCAL Diagnostics Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| • 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 | — |
Countries
India
Contacts
Public ContactRaghu Ram Pillarisetti
KIMS Hospital
Outcome results
None listed