Clinical Evidence

UNRAVELLING CELL-BASED CANCER BIOMARKERS

Clinical studies for prostate cancer were performed at Siriraj Hospital, Bangkok, Thailand, IRB approval no. SI402/2015.

Phase 1

December 2015 – March 2016

Setup Blood samples from 120 patients with PSA >4ng/ml receiving prostate biopsy were examined for cells associated with positive biopsies.

Results Over 80% of patients carried tumor-derived circulating endothelial cells, while less than 10% carried epithelial circulating tumor cells – indicating that targeting the complete range of circulating tumor-derived cells significantly increases sensitivity of cancer detection.

Phase 2

August 2016 – December 2016

Setup Cells isolated from blood samples of 60 patients with PSA >4ng/ml and scheduled for prostate biopsy were examined for tumor derived endothelial markers, mesenchymal, epithelial and cell proliferation markers as well as nuclear morphology. Analysis of blood samples was performed blinded against biopsy results. In addition, 40 healthy donors were screened for cancer cells.

Results 86% sensitivity and 70% specificity when compared to biopsy results. 100% specificity in the group of healthy controls.

Phase 3

January 2018 – TBA

Setup Blood samples from 1,000 patients with elevated PSA tests are examined for tumour-derived endothelial cells, mesenchymal, epithelial and cell proliferation markers. Patients positive for cancer cells, but with a negative biopsy, receive prostate MRI scans and fusion biopsy as indicated. Patients negative for cancer cells receive prostate biopsy as planned (negative blood tests do not affect physician’s decision to biopsy).

Study endpoints Rate of false negative biopsies, rate of false negative blood tests. Overall sensitivity of biopsy vs. blood test.

Phase 4

November 2017 – January 2018

Setup Blood samples from 300 patients who underwent mammography and were classified as BIRADS 4 are examined for tumour-derived circulating cells. In addition, samples from 50 patients classified BIRADS 1 or 2 and samples from 50 patients classified BIRADS 5 are processed as additional negative and positive controls.

Results TBA

References

1Chaffer & Weinberg (2011). A perspective on cancer cell metastasis. Science, 331(6024), 1559–1564. https://doi.org/10.1126/science.1203543

2Cima et al. (2016). Tumor-derived circulating endothelial cell clusters in colorectal cancer. Science Translational Medicine, 8(345), 345ra89.

3Bhakdi & Malasit. (2011). High gradient magnetic separation of biological material. EP 2 190 585 B1 and depending patents

4Bhakdi (2017). Compositions and methods for identifying rare cells. PCT/US17/20905

5Bhakdi et al. (2010). Optimized high gradient magnetic separation for isolation of Plasmodium-infected red blood cells. Malaria Journal, 9, 38. https://doi.org/10.1186/1475-2875-9-38

6Waseem et al. (2016). Buffer-Optimized High Gradient Magnetic Separation : Target Cell Capture Efficiency is Predicted by Linear Bead-Capture Theory. Journal of Magnetics, 21(1), 125–132.

7 AUA White Paper on THE PREVENTION AND TREATMENT OF THE MORE COMMON COMPLICATIONS RELATED TO PROSTATE BIOPSY UPDATE. The American Urological Association, 2016

 

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