Colorectal Cancer (CRC) Clinical Trial
Official title:
A Novel Patent Platform of Detection of Circulating Tumor Cells to Early Detect Colorectal Cancer Recurrence
The best strategy to prevent colorectal cancer (CRC) death lies in early detection and early
treatment at the local disease status of tumor. After curative resection of tumor, there are
about 5~10% of stage I, 20~30% of stage II and 40~50% of stage III patients suffering
metastasis during subsequent follow-up periods. Although carcinoembryonic antigen (CEA) is
the most widely used biomarker for postoperative monitoring of recurrence on asymptomatic
patients, it is difficult to use CEA as biological marker to identify the population with
high recurrent risk in patients with early-stage cancer because lower than half of patients
with early-stage cancer do not have CEA elevation. For improving the survival of patients
with early-stage CRC, we need effort to search more useful biological markers to predict the
risk of tumor recurrence and to select out patients with high recurrent risk to receive
preventive adjuvant therapy.
Circulating tumor cells (CTCs) in the blood play an essential role in cancer metastasis.
Hence, the detection of CTCs and subsequent analysis can potentially revolutionize the
cancer care ranging from screening, diagnosis, monitoring, to drug selection and so on. In
the past decade, many methods using magnetic beads (CellSearch), filtration (RareCelletc),
or flow cytometry have been developed but all of them have the shortcomings from low
sensitivity, low purity, to unable to retrieve cells for downstream molecular analysis and
cell culture. Recently, a biomimetic affinity based microfluidic platform has overcome
abovementioned technical challenges. Importantly, by using only 2 ml of peripheral blood,
Sinica's team has shown that the enumeration of CTCs increases with the CRC disease
progression, where the mean CTC counts are 3, 15, 29 and 60 per ml for the stages I, II, III
and IV, respectively. The results imply that monitoring CTC enumeration serially may serve
as a prediction marker to identify the CRC patients with high probability of recurrence. The
aims of this study are toestablishing CTC platform standard operation protocol (SOP) that
leads to certification of ISO 13485 and to establish CTC criteria and evaluate its
prediction power of early detection of colorectal cancer recurrence.
n/a
Observational Model: Case-Only, Time Perspective: Prospective
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