10.Can you provide anonymous clinical data (without patients’ personal information) from hospitals? Including the prognosis of cancer within a year.

 

The gold standard for the evaluation of CDP scores is permeant pathology of cavity side margins. CDP works based on permanent pathology as the gold standard and is not a prognostic device. Since all involved margins should be resected from the patient’s body according to breast cancer surgical guidelines, and CDP is calibrated with permanent pathology, positive cavity side margins are recommended to dissect.

As can be seen from the table, a reduction of about 30% of the involved margins remaining in the patient’s body with the help of CDP despite performing frozen-section and permanent pathology on tumor side margins occurred. Remaining positive margins in breast-conserving surgery are associated with an increased risk of local recurrence, leading to healthcare costs and mental and physical stress. Direct checking of cavity side margins after tumor excision may prevent the tumor bed from remaining tumor residues/satellite/scattered cancer cells. Published reports indicated that more than 20% of the involved margins, still couldn’t be diagnosed intra-operatively by conventional intra-operative methods such as frozen section and X-ray evaluation of dissected tumor margins. It is also necessary to take all the involved lymph nodes out of the body to decrease the risk of local recurrences.

Cancer Diagnostic Probe (CDP), a real-time diagnostic system as a complementary surgeon-assisted tool, along with Frozen-section and Permanent pathologies, is used to detect high-risk pre-cancer/cancer cells in the cavity side margins and cancerous cells in lymph nodes of patients undergoing breast cancer surgery.

 

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