Increasing the CTC detection sensitivity through FETCH technology

In many cancer types, the number of circulating tumour cells (CTC) detected by
the FDA-cleared CellSearch system in a 7,5mL blood sample is predictive of
disease prognosis, treatment outcome and relapse prediction. Additionally the
makeup of these cells can be used to signal tumour changes such as those
underlying resistance. However, due to their low frequency, the detected number
of CTC currently found in standard blood tube using the CellSearch system is
often 0. In light of recent findings on the low expression of the antigen used
by the CellSearch system for CTC capture, we believe that using a more
sensitive method of CTC detection makes it possible to detect and characterize
CTC in a larger percentage of cancer patients.

Compare the CTC recovery of the CellSearch system for CTC detection to a newly
developed method for CTC detection.

The study is a performance study where two blood tubes from each patient will
be processed simultaneously using two methods and the detected numbers of CTC
will be compared.

The participants will have two additional tubes of blood taken during a regular
visit. No additional venipuncture will be performed.

This will prolong the existing blood collection procedure by approximately 1-2
minutes.