Colorectal Cancer Clinical Trial
Official title:
Effectiveness of Multi-target FIT-DNA Analysis as a Colorectal Cancer Screening Test
Colorectal cancer is one of the most common cancer in Hong Kong. In 2018, CRC accounted for
17.4%, 5,780 cases, of the total new cancers. CRC claimed 2,279 lives (15.8%) making it the
second most deadly killer in the population.
Since 2010, the Cancer Expert Working Group (CEWG) has recommended that asymptomatic
average-risk individuals aged 50 to 75 years should consider one of the screening methods:
fecal occult blood test (FOBT) every one to two years; OR flexible sigmoidoscopy every 5
years; OR colonoscopy every 10 years. However, it poses great challenges for large scale CRC
screening using colonoscopy, such as bowel preparation difficulties, complications of
procedure and poor compliance.
ColoClear® is intended for use as an adjunctive screening test for the detection of
colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in
human stool. It has the potential of increasing the sensitivity of detecting CRC as compared
to FOBT or faecal immunochemical test (FIT), which detects the presence of hemoglobin in
stool alone. A positive result may indicate the presence of colorectal cancer or
pre-malignant colorectal neoplasia. ColoClear® is not intended as a replacement for
diagnostic colonoscopy. A positive result in ColoClear®, as with any screening test, should
be followed by colonoscopy. ColoClear® is intended for colorectal cancer screening in average
risk individuals: adults of either sex, 40 years or older, who are at high risk for
colorectal cancer.
The objective of this study is to evaluate the clinical performance of ColoClear test in early screening of colorectal cancer in Hong Kong. Other outcomes to analyze include, but are not limited to the point estimate of the sensitivity of ColoClear for the detection of advanced adenoma (AA) in Hong Kong. ;
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