Stool-based SDC2 DNA Methylation Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer
NCT ID: NCT04221854
Last Updated: 2020-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50000 participants
INTERVENTIONAL
2020-01-06
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Stool-based SDC2 DNA methylation test group
Subjects will received the stool-based SDC2 DNA methylation test for the screening of colorectal advanced adenomatous polyps and cancer.
Stool-based SDC2 DNA methylation test
Stool-based SDC2 DNA methylation test
Fecal immunochemical test group
Subjects will received the fecal immunochemical test for the screening of colorectal advanced adenomatous polyps and cancer.
Fecal immunochemical test
Fecal immunochemical test
Interventions
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Stool-based SDC2 DNA methylation test
Stool-based SDC2 DNA methylation test
Fecal immunochemical test
Fecal immunochemical test
Eligibility Criteria
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Inclusion Criteria
2. Subject is able and willing to undergo a screening colonoscopy within six months of enrollment.
3. Subject is 45 to 80 years of age inclusive.
4. Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
5. Subject is able and willing to provide stool samples according to written instructions provided to them.
Exclusion Criteria
2. Subject has a history of colorectal cancer or adenoma.
3. Subject has a history of other digestive tract cancer.
45 Years
80 Years
ALL
Yes
Sponsors
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Shanghai Municipal Center for Disease Control and Prevention
OTHER
Changhai Hospital
OTHER
Tianjin Nankai Hospital
OTHER
Peking University People's Hospital
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
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Responsible Party
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Ping Lan
Professor
Principal Investigators
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Kai Gu, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Municipal Center for Disease Control and Prevention
Enda Yu, MBBS
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Ximo Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Tianjin Nankai Hospital
Shan Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Jiahua Leng, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Dong Xu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Pengzhe Qin, MD
Role: PRINCIPAL_INVESTIGATOR
Guangzhou Center for Disease Control and Prevention
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Jiahua Leng, MD, PhD
Role: primary
Shan Wang, MD, PhD
Role: primary
Pengzhe Qin, MD
Role: primary
Dong Xu, MD, PhD
Role: primary
Enda Yu, MBBS
Role: primary
Kai Gu
Role: primary
Ximo Wang, MD, PhD
Role: primary
Other Identifiers
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CCRCSIP
Identifier Type: -
Identifier Source: org_study_id
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