Colo-rectal Cancer Clinical Trial
Official title:
Application of an Automated Liquid Biopsy System in the Detection of Colorectal Cancer
Colorectal cancer (CRC) is among the most preventable cancers when precancerous lesions are
detected at an early stage. Current screening methods for CRC require bowel prep or
stool-based testing that are inconvenient, resulting in low compliance. Stool based tests
have limited sensitivity for the detection of precancerous lesions.
The CMx platform has been showed to be able to the detection of Circulating Tumor Cells
(CTCs) in high sensitivity and specificity. In published studies, circulating Tumor Cells
(CTCs) are captured and quantified in advanced-stages of colorectal cancer. In order to
detect early and pre-cancer circulating tumor cells, we have developed an Automated Liquid
Biopsy Platform that improves the detection of CTCs in early cancer stages. Therefore, this
study goals are: 1) to establish a standard detection process utilizing the Automated Liquid
Biopsy Platform. 2) Parallel comparison of laboratory manual operation and Automated Liquid
Biopsy Platform. 3) Verify the feasibility of use of an Automated Liquid Biopsy Platform in
the clinical setting.
1. Selection of patients:
A. The disease group includes 300 patients diagnosed with stages 0-4 colorectal cancer
not previously treated.
B. The control group includes 450 control subjects who will undergo a colonoscopy
procedure.
2. Study stages
Stage I: The laboratory manually analyzes circulating tumor cells to establish a
standard detection process for Automated Liquid Biopsy System
Stage II: Comparison analysis between manual and Automated Liquid Biopsy Platform,
establishing the procedural and analytical models for the Automated Liquid Biopsy
Platform
Stage III: Verification of the feasibility of use of an Automated Liquid Biopsy Platform
in the clinical setting.
3. Methods
I. CTC isolation Peripheral blood drawn from subjects will be processed using the CMx
platform or the automated liquid biopsy system for detection and capture.
II. Characterization of isolated CTC using Immunofluorescence Staining
III. CRC-related gene expression The serum and circulating tumor cells isolated from the
blood will be used to extract RNA, and then be analyzed with the expression of different
genes by real-time quantitative polymerase chain reaction (real-time PCR).
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