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| Name | Class |
|---|---|
| Shanghai Municipal Center for Disease Control and Prevention | OTHER |
| Changhai Hospital | OTHER |
| Tianjin Nankai Hospital | OTHER |
| Peking University People's Hospital |
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The primary objective is to compare the performance of Stool-based SDC2 DNA Methylation Test and commercially available Fecal Immunochemical Test(FIT) , on the detection rate of advanced adenomatous polyps and colorectal cancer in Chinese population. Subjects with positive results in either test will receive colonoscopy. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
A large cohort of participants will be asked to collect stool sample for either Stool-based SDC2 DNA Methylation Test or Fecal Immunochemical Test. Subjects who have positive results will undergo colonoscopy within 6 months.
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 |
|---|---|---|---|
| Stool-based SDC2 DNA methylation test group | Experimental | Subjects will received the stool-based SDC2 DNA methylation test for the screening of colorectal advanced adenomatous polyps and cancer. |
|
| Fecal immunochemical test group | Active Comparator | Subjects will received the fecal immunochemical test for the screening of colorectal advanced adenomatous polyps and cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stool-based SDC2 DNA methylation test | Diagnostic Test | Stool-based SDC2 DNA methylation test |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Detection Rate of Colorectal Polyps, Advanced Adenomatous Polyps and Cancer by Two Screening Methods | The stool-based SDC2 DNA methylation test CT values of 38 or less compared to beta-actin considered to be positive. Fecal immunochemical test values of more than 100 ng of hemoglobin per milliliter of buffer were considered as positive. An optical colonoscopy is used as diagnostic method. Lesions will be confirmed by histopathologic examination. | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ping Lan, M.D., Ph.D. | Contact | +86-13710316769 | lanping@mail.sysu.edu.cn | |
| Yufeng Chen, MD, PhD | Contact | +86-13710555130 | chenyf78@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Kai Gu, MD | Shanghai Municipal Center for Disease Control and Prevention | Principal Investigator |
| Enda Yu, MBBS | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41334638 | Derived | Chen Y, Li J, Gu K, Ding K, Qin P, Pei Z, Gong Y, Xu D, Liang Y, Yang D, Dou J, Huang Y, Hu J, Wu P, Zhang S, Wang W, Shi L, Liu Q, Li C, Li W, Wang X, Lan P, Liang B, He X. Stool-based methylated syndecan-2 test and fecal immunochemical test for advanced colorectal neoplasia screening in the Chinese population: A multicenter randomized noncomparative study. Chin Med J (Engl). 2025 Dec 3. doi: 10.1097/CM9.0000000000003897. Online ahead of print. |
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| OTHER |
| Peking University Cancer Hospital & Institute | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| Guangzhou Center for Disease Control and Prevention | OTHER_GOV |
Subjects will received either Stool-based SDC2 DNA Methylation Test or Fecal Immunochemical Test.
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| Fecal immunochemical test | Diagnostic Test | Fecal immunochemical test |
|
| Ximo Wang, MD, PhD |
| Tianjin Nankai Hospital |
| Principal Investigator |
| Shan Wang, MD, PhD | Peking University People's Hospital | Principal Investigator |
| Jiahua Leng, MD, PhD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Dong Xu, MD, PhD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Pengzhe Qin, MD | Guangzhou Center for Disease Control and Prevention | Principal Investigator |
| Beijing Cancer Hospital | Recruiting | Beijing | China |
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| Peking University People's Hospital | Recruiting | Beijing | China |
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| Guangzhou Center for Disease Control and Prevention | Recruiting | Guangzhou | China |
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| Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | China |
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| Changhai Hospital | Recruiting | Shanghai | China |
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| Shanghai Municipal Center for Disease Control and Prevention | Recruiting | Shanghai | China |
|
| Tianjin Nankai Hospital | Recruiting | Tianjin | 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 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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