Colorectal Cancer, Adenomatous Polyps, Adenoma, Advanced Adenoma
Conditions
Keywords
Cancer, Colorectal Cancer, Colorectal Neoplasms, Adenomatous Polyps, Adenoma, Advanced adenoma, Gastrointestinal Diseases, Colonic Diseases, Neoplasms, Digestive System Diseases, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Intestinal Diseases, Rectal Diseases, Glandular and Epithelial, Neoplasms by Histologic Type
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTMultitarget stool FIT-DNA test - ColoClear
Multitarget stool FIT-DNA test
DIAGNOSTIC_TESTFIT
fecal immunochemical test
PROCEDUREColonoscopy
diagnostic colonoscopy
Sponsors
New Horizon Health Technology Co., Ltd
Beijing Mingze Technology Co., Ltd.
Zhejiang University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
* Willing to provide written consent * Able to provide stool sample For high risk CRC screening group: * Scheduled for colonoscopy voluntarily or by physician prescription * CRC high risk profile as defined below: * History of FIT positivity * Family history of CRC * Any of two of the following clinical symptoms: chronic constipation/diarrhea, stool with mucous, chronic appendicitis, chronic bilary track diseases, mental stress For CRC group: * Confirmed CRC patients * No prior treatment with chemotherapy, radiotherapy, and prior to any surgical procedures
Exclusion criteria
* Unwilling to provide stool samples * FAP (familial adenomatous polyposis), Crohn's disease, ulcerative colitis * Prior history of colonoscopy within the past 5 years and removal of lesions * History of CRC * other conditions deemed not suited for the study by investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of the ColoClear screening test with comparison to colonoscopy | Through study completion, an average of 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the ColoClear screening test with comparison to FIT, with respect to advanced adenoma (AA) and CRC | Through study completion, an average of 1 year | 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. |
Countries
China
Outcome results
None listed