Colorectal CancerNCT04221854
Stool-based SDC2 DNA Methylation Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer
A study testing Stool-based SDC2 DNA methylation test and Fecal immunochemical test in people with Colorectal Cancer and Colorectal Adenomatous Polyp, run by Sixth Affiliated Hospital, Sun Yat-sen University at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Adenomatous Polyp, Screening
- What is being tested?
- Stool-based SDC2 DNA methylation test and Fecal immunochemical test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50,000 participants
- Where
- 8 sitesChina
- Study dates
- 6 Jan 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
Jiahua Leng, MD, PhD
Jiahua Leng, MD, PhD
- Recruiting
Peking University People's Hospital
Beijing
Shan Wang, MD, PhD
Shan Wang, MD, PhD
- Recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Ping Lan, MD, PhD, +86-13710316769, lanping@mail.sysu.edu.cn
Ping Lan, MD, PhD
- Recruiting
Guangzhou Center for Disease Control and Prevention
Guangzhou
Pengzhe Qin, MD
Pengzhe Qin, MD
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
Dong Xu, MD, PhD
Dong Xu, MD, PhD
- Recruiting
Changhai Hospital
Shanghai
Enda Yu, MBBS
Enda Yu, MBBS
- Recruiting
Shanghai Municipal Center for Disease Control and Prevention
Shanghai
Kai Gu
Kai Gu, PhD
- Recruiting
Tianjin Nankai Hospital
Tianjin
Ximo Wang, MD, PhD
Ximo Wang, MD, PhD
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Cancer, Colorectal Adenomatous Polyp, Screening
- Being tested
- Stool-based SDC2 DNA methylation test, Fecal immunochemical test
- Keywords
- Colorectal cancer screening, SDC2 DNA Methylation, Fecal immunochemical test
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool-based SDC2 DNA methylation testDiagnostic test
Stool-based SDC2 DNA methylation test
Fecal immunochemical testDiagnostic test
Fecal immunochemical test
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Stool-based SDC2 DNA methylation test |
| Fecal immunochemical test group | Active comparator | Subjects will received the fecal immunochemical test for the screening of colorectal advanced adenomatous polyps and cancer. Receives: Diagnostic Test: Fecal immunochemical test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start6 Jan 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will received either Stool-based SDC2 DNA Methylation Test or Fecal Immunochemical Test.
- Masking
- None (open label)
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Center for Disease Control and Prevention, Changhai Hospital, Tianjin Nankai Hospital, Peking University People's Hospital, Peking University Cancer Hospital & Institute, Second Affiliated Hospital, Zhejiang University, School of Medicine, Guangzhou Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Ping Lan, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Kai Gu, MD, Principal investigator, Shanghai Municipal Center for Disease Control and PreventionEnda Yu, MBBS, Principal investigator, Changhai HospitalXimo Wang, MD, PhD, Principal investigator, Tianjin Nankai HospitalShan Wang, MD, PhD, Principal investigator, Peking University People's HospitalJiahua Leng, MD, PhD, Principal investigator, Peking University Cancer Hospital & InstituteDong Xu, MD, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of MedicinePengzhe Qin, MD, Principal investigator, Guangzhou Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221854
- Sponsor's protocol ID
- CCRCSIP
- Status last verified
- Feb 2020
- First submitted
- 6 Jan 2020
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41334638
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04221854
- Acronym / sponsor ID
- CCRCSIP
- Conditions
- Colorectal Cancer, Colorectal Adenomatous Polyp, Screening
- Keywords
- Colorectal cancer screening, SDC2 DNA Methylation, Fecal immunochemical test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Shanghai Municipal Center for Disease Control and Prevention, Changhai Hospital, Tianjin Nankai Hospital, Peking University People's Hospital, Peking University Cancer Hospital & Institute, Second Affiliated Hospital, Zhejiang University, School of Medicine, Guangzhou Center for Disease Control and Prevention
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will received either Stool-based SDC2 DNA Methylation Test or Fecal Immunochemical Test.
| Arm | Type | Receives |
|---|---|---|
| Stool-based SDC2 DNA methylation test group | Experimental | Diagnostic Test: Stool-based SDC2 DNA methylation testSubjects 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 | Diagnostic Test: Fecal immunochemical testSubjects will received the fecal immunochemical test for the screening of colorectal advanced adenomatous polyps and cancer. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool-based SDC2 DNA methylation testStool-based SDC2 DNA methylation test | Diagnostic test | Stool-based SDC2 DNA methylation test group |
| Fecal immunochemical testFecal immunochemical test | Diagnostic test | Fecal immunochemical test group |
Primary outcome
The Detection Rate of Colorectal Polyps, Advanced Adenomatous Polyps and Cancer by Two Screening Methods
Time frame: One year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Derived from this study: PubMed 41334638Chen 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai Gu, MD principal investigator
Shanghai Municipal Center for Disease Control and Prevention
Enda Yu, MBBS principal investigator
Changhai Hospital
Ximo Wang, MD, PhD principal investigator
Tianjin Nankai Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stool-based SDC2 DNA methylation test and Fecal immunochemical test in people with Colorectal Cancer and Colorectal Adenomatous Polyp, run by Sixth Affiliated Hospital, Sun Yat-sen University at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping Lan, M.D., Ph.D. (+86-13710316769, lanping@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Detection Rate of Colorectal Polyps, Advanced Adenomatous Polyps and Cancer by Two Screening Methods (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04221854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.