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| Name | Class |
|---|---|
| Changhai Hospital | OTHER |
| Tianjin Nankai Hospital | OTHER |
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The primary objective is to determine the sensitivity and specificity of two Colorectal Cancer (CRC) screening methods, including stool DNA test and blood mRNA test, for colorectal cancer in Chinese population, with colonoscopy as reference method. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
The secondary objective is to compare the performance of these two CRC screening methods to a commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
Participants who are at high risk of developing colorectal cancer will be asked to collect two stool samples one for the stool DNA test and the other for the commercially available FIT assay, and a single blood sample for the blood mRNA test. Subjects will undergo colonoscopy within 6 months of enrollment. Representative histopathology slides from tissue biopsied or excised during colonoscopy and those from subsequent definitive surgery may be retrieved in order to be evaluated by pathologists to confirm the diagnosis and staging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mutiple screening test group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stool DNA test | Diagnostic Test | Stool DNA test could detect specific gene methylation in stool DNA. Blood mRNA test could detect specific set of gene expression in blood. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of Multiple Screening Methods With Comparison to Colonoscopy, Both With Respect to Cancer. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants at high risk of developing colorectal cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongzhi Zou, MD, PhD | Contact | 86-020-82510982 | zouhongzhi@creativebio.cn | |
| Yan Qi, PhD | Contact | 86-020-82510982 | qiyan@creativebio.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hongzhi Zou, MD, PhD | The Sixth Affiliated Hospital, Sun Yet-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliated Hospital, Sun Yet-sen University | Recruiting | Guangzhou | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Changhai Hospital | Recruiting | Shanghai | China |
|
| Tianjin Nankai Hospital | Recruiting | Tianjin | China |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |