Spots Global Cancer Trial Database for Stool-based SDC2 DNA Methylation Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer
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Trial Identification
Brief Title: Stool-based SDC2 DNA Methylation Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer
Official Title: Stool-based SDC2 DNA Methylation Test vs. Fecal Immunochemical Test on the Detection of Colorectal Advanced Adenomatous Polyps and Cancer in Chinese Population: A Multi-central Randomized Clinical Trial
Study ID: NCT04221854
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 45 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Beijing Cancer Hospital, Beijing, , China
Peking University People's Hospital, Beijing, , China
Guangzhou Center for Disease Control and Prevention, Guangzhou, , China
Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, , China
Changhai Hospital, Shanghai, , China
Shanghai Municipal Center for Disease Control and Prevention, Shanghai, , China
Tianjin Nankai Hospital, Tianjin, , China
Contact Details
Name: Kai Gu, MD
Affiliation: Shanghai Municipal Center for Disease Control and Prevention
Role: PRINCIPAL_INVESTIGATOR
Name: Enda Yu, MBBS
Affiliation: Changhai Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Ximo Wang, MD, PhD
Affiliation: Tianjin Nankai Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Shan Wang, MD, PhD
Affiliation: Peking University People's Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Jiahua Leng, MD, PhD
Affiliation: Peking University Cancer Hospital & Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Dong Xu, MD, PhD
Affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
Role: PRINCIPAL_INVESTIGATOR
Name: Pengzhe Qin, MD
Affiliation: Guangzhou Center for Disease Control and Prevention
Role: PRINCIPAL_INVESTIGATOR
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