The primary objective is to determine the diagnostic sensitivity and specificity of the newly developed multitarget FIT-DNA Colorectal Cancer (CRC) screening test (ColoClear) for detecting advanced neoplasia (including colorectal cancer and advanced adenomas) in high risk patients, using colonoscopy as the reference method. The secondary objective is to compare the screening performance of the multitarget FIT-DNA test with commercially available FIT (Fecal Immunochemical Test) assay in detecting advanced neoplasia.
The study will be carried out in 8 tier-3A hospitals throughout China. Patients who are at high risk of developing colorectal cancer and willing to conduct colonoscopy examination will be asked to collect stool sample prior to bowl preparation for multitarget FIT-DNA test and commercially available FIT assay. Colonoscopy and histopathologic examination are used as reference.
Study Type
OBSERVATIONAL
Enrollment
4,758
Multitarget stool FIT-DNA test
fecal immunochemical test
diagnostic colonoscopy
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Sensitivity and specificity of the ColoClear screening test with comparison to colonoscopy
A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The DNA test includes molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, plus a hemoglobin immunoassay. A logistic-regression algorithm incorporating all the above parameters was deployed to compute a single composite score, with values of 165 or more considered to be positive. The tests were processed independently of colonoscopy procedure.
Time frame: Through study completion, an average of 1 year
Sensitivity of the ColoClear screening test with comparison to FIT, with respect to advanced adenoma (AA) and CRC
A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The ColoClear and FIT test were performed on the same stool sample.
Time frame: Through study completion, an average of 1 year
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