Predictive value of Leukocyte Immuno Test in breast cancer metastasis
Research type
Research Study
Full title
Investigative pilot study of the diagnostic potential of a rapid point-of-care blood test in distinguishing between non-metastatic and metastatic breast cancer
IRAS ID
326689
Contact name
Pankaj Gupta (PG) Roy
Contact email
Sponsor organisation
Seroxo
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
Breast cancer is the most common cancer worldwide and a leading cause of cancer-related death. Despite improvements in survival rates, a significant number of patients eventually develop distant metastasis after initial treatment. Metastatic breast cancer is difficult to diagnose and current tests including CT, MRIs, and PET scans are expensive and have low throughput. Biomarkers for metastatic cancer require specialised laboratory equipment, yet, their clinical utility is limited. This study aims to investigate the use of a point-of-care test LIT in distinguishing between non-metastatic and metastatic breast cancer. LIT assesses patients' immune function via the measurement of reactive oxygen species from their white blood cells in response to a proprietary reagent. 10µl finger-prick blood will be collected from patients for the LIT test and their LIT scores will then be compared with other histology or haematology data. The predictive value of LIT in cancer has previously been demonstrated in prostate cancer patients, as well as other 25 different cancers. It is highly likely that LIT will show similar predictive value in breast cancer, and the ability to detect metastatic cancer for previously diagnosed breast cancer patients with a simple, scalable, and affordable test would significantly advance the management of this disease. This would allow earlier intervention, which could improve patient outcomes and potentially reduce the number of deaths from breast cancer. In addition, the LIT test is non-invasive and easy to use at home, which could improve the patient experience and reduce the stress and anxiety associated with visiting hospitals and clinics. The health economic impact of LIT is also huge as it may produce significant long-term cost savings for the NHS if LIT test can be used in the detection of metastatic breast cancer, instead of expensive MRI/PET scans.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
23/YH/0197
Date of REC Opinion
18 Oct 2023
REC opinion
Further Information Favourable Opinion