Stool-based SDC2 DNA Methylation Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer
1 other identifier
interventional
50,000
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Jan 2020
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2020
CompletedStudy Start
First participant enrolled
January 6, 2020
CompletedFirst Posted
Study publicly available on registry
January 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFebruary 18, 2020
February 1, 2020
2 years
January 6, 2020
February 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Stool-based SDC2 DNA methylation test group
EXPERIMENTALSubjects will received the stool-based SDC2 DNA methylation test for the screening of colorectal advanced adenomatous polyps and cancer.
Fecal immunochemical test group
ACTIVE COMPARATORSubjects will received the fecal immunochemical test for the screening of colorectal advanced adenomatous polyps and cancer.
Interventions
Stool-based SDC2 DNA methylation test
Eligibility Criteria
You may qualify if:
- Subject is average risk for development of colorectal cancer.
- Subject is able and willing to undergo a screening colonoscopy within six months of enrollment.
- Subject is 45 to 80 years of age inclusive.
- Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
- Subject is able and willing to provide stool samples according to written instructions provided to them.
You may not qualify if:
- Subject has any condition which, in the opinion of the investigator should preclude participation in the study.
- Subject has a history of colorectal cancer or adenoma.
- Subject has a history of other digestive tract cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen Universitylead
- Shanghai Municipal Center for Disease Control and Preventioncollaborator
- Changhai Hospitalcollaborator
- Tianjin Nankai Hospitalcollaborator
- Peking University People's Hospitalcollaborator
- Peking University Cancer Hospital & Institutecollaborator
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitycollaborator
- Guangzhou Center for Disease Control and Preventioncollaborator
Study Sites (8)
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655, 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
Related Publications (1)
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.
PMID: 41334638DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kai Gu, MD
Shanghai Municipal Center for Disease Control and Prevention
- PRINCIPAL INVESTIGATOR
Enda Yu, MBBS
Changhai Hospital
- PRINCIPAL INVESTIGATOR
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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 6, 2020
First Posted
January 9, 2020
Study Start
January 6, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
February 18, 2020
Record last verified: 2020-02