Colorectal CancerNCT05374369
Retrospective Analysis of Colorectal Cancer Screening Results
An observational study of Colorectal Cancer and Advanced Adenocarcinoma, run by Creative Biosciences (Guangzhou) Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to retrospectively analyze colorectal cancer screening data of 40-74 year old population in Shipai Town, Dongguan City. In this study, the data of SDC2 Gene Methylation Test and Fecal Immunochemistry Test (Q-FIT) were screened from about 11,000 subjects who participated in Colorectal… Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Colorectal Cancer, Advanced Adenocarcinoma, Hyperplastic Polyp
- What is being tested?
- SDC2 Gene Methylation Test and Q-FIT Test and Colonoscopy and/or pathological examination
- Type of treatment
- Surgery or procedure
- How many people
- 822 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2022to 28 Apr 2022
- Phase
- Observational
- 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 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects live in Shipai Town, Dongguan city, the age limit is 40-74 years，822 subjects meet the inclusion criteria for this study.
Who may be able to join
- Subjects must meet both of the following criteria to be eligible for the study:
- Subjects with positive SDC2 Gene Methylation Test and/or Q-FIT;
- Subjects with colonoscopy and/or pathological results.
Who cannot join
- Subject with any of the following conditions shall be excluded:
- Data Missing or damaged;
- Unqualified colonoscopy or unqualified stool test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of Colorectal Cancer Screening Results Among People Aged 40-74 in Shipai Town, Dongguan City, China
The purpose of this study is to retrospectively analyze colorectal cancer screening data of 40-74 year old population in Shipai Town, Dongguan City.
In this study, the data of SDC2 Gene Methylation Test and Fecal Immunochemistry Test (Q-FIT) were screened from about 11,000 subjects who participated in Colorectal Cancer Screening in Shipai Town People's Livelihood Project from May 2021 to May 2022. Data from 822 subjects with positive SDC2 Gene Methylation Test and/or positive Fecal Immunochemistry Test (Q-FIT) results and with colonoscopy and/or pathological results were selected for retrospective analysis.
This retrospective study evaluated the screening performance of SDC2 Gene Methylation Test and/or Fecal Immunochemistry Test (Q-FIT) for colorectal cancer using colonoscopy and/or pathological results as the clinical standard method.
Read the detailed description
This study is a retrospective and observational study. Subjects were not be given or offered any treatment during the study. The investigator reviewed the patient's medical history and examination report to determine eligibility based on inclusion and exclusion criteria.
This study retrospectively analyse the basic information and the test results of SDC2 Gene Methylation Test and Fecal Immunochemistry Test (Q-FIT) of about 11,000 subjects who participated in the Colorectal Cancer Screening in Shipai Town People's Livelihood Project from May 2021 to May 2022. A total of 822 subjects with positive SDC2 Gene Methylation Test results and / or positive Fecal Immunochemistry Test (Q-FIT) results were screened out and their colonoscopy results were collected.
822 subjects were classified according to colonoscopy and/or pathological detection results, and the screening performance of the SDC2 Gene Methylation Test and Fecal Immunochemistry Test (Q-FIT) for colorectal cancer was statistically analyzed.
- Conditions
- Colorectal Cancer, Advanced Adenocarcinoma, Hyperplastic Polyp, Colorectal Neoplasms, Digestive System Neoplasm, Neoplasms
- Being tested
- SDC2 Gene Methylation Test and Q-FIT Test, Colonoscopy and/or pathological examination
- Keywords
- Colorectal Cancer, Colon Cancer, Stool DNA test, Fecal DNA test, Fecal Immunochemical Test, FIT, Methylation Biomarkers, Colonoscopy, Cancer Screening
- Medical subject headings
- Colorectal Neoplasms, Digestive System Neoplasms, Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDC2 Gene Methylation Test and Q-FIT TestDiagnostic test
Stool specimens were collected by the subjects for SDC2 Gene Methylation Test and Q-FIT Test
Colonoscopy and/or pathological examinationProcedure or surgery
Subjects underwent colonoscopy and/or pathological examination.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with positive SDC2 Gene Methylation Test | Subjects must meet both of the following criteria to be eligible for the study:
1. Subjects with positive SDC2 Gene Methylation Test;
2. Subjects with colonoscopy results and/or pathological results. Receives: Diagnostic Test: SDC2 Gene Methylation Test and Q-FIT Test; Procedure: Colonoscopy and/or pathological examination | |
| Subjects with positive Q-FIT Test | Subjects must meet both of the following criteria to be eligible for the study:
1. Subjects with positive Q-FIT Test;
2. Subjects with colonoscopy results and/or pathological results. Receives: Diagnostic Test: SDC2 Gene Methylation Test and Q-FIT Test; Procedure: Colonoscopy and/or pathological examination | |
| Subjects with positive SDC2 Gene Methylation Test and Q-FIT Test | Subjects must meet both of the following criteria to be eligible for the study:
1. Subjects with positive SDC2 Gene Methylation Test and Q-FIT Test;
2. Subjects with colonoscopy results and/or pathological results. Receives: Diagnostic Test: SDC2 Gene Methylation Test and Q-FIT Test; Procedure: Colonoscopy and/or pathological examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive value (PPV)
PPV is the number of real positive cases in the total number of stool gene DNA methylation detection positive or/and Q-FIT positive.
Measured: one month
Sensitivity
Sensitivity is the percentage of subjects with colon cancer who are correctly identified by the testing kit.
Measured: one month
Tumor detection rate in the positive screening results
Compare to clinical standard method results, the tumor detection rates of the three groups were analyzed.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start29 Mar 2022
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 822 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creative Biosciences (Guangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dongguan Shipai Hospital
- Responsible party
- Sponsor
- Investigators
- Zhi Zhang, Principal investigator, Dongguan Shipai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374369
- Sponsor's protocol ID
- KLM2021-03
- Status last verified
- Mar 2022
- First submitted
- 10 May 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are carefully considering all applicable regulations and laws governing sharing of patients' data from China online with the global public.
Publications
Kong X, Wu Q, Zhang Z, Yu Z, Niu F, Wang X, Zou H. Effectiveness of single-target fecal DNA methylation test in regional mass screening for colorectal cancer and precancerous lesions in China. Gastroenterol Rep (Oxf). 2025 Apr 15;13:goaf029. doi: 10.1093/gastro/goaf029. eCollection 2025.
PubMed 40241850
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Colorectal Cancer Screening Results Among People Aged 40-74 in Shipai Town, Dongguan City, China
- ClinicalTrials.gov ID
- NCT05374369
- Acronym / sponsor ID
- KLM2021-03
- Conditions
- Colorectal Cancer, Advanced Adenocarcinoma, Hyperplastic Polyp, Colorectal Neoplasms, Digestive System Neoplasm, Neoplasms
- Keywords
- Colorectal Cancer, Colon Cancer, Stool DNA test, Fecal DNA test, Fecal Immunochemical Test, FIT, Methylation Biomarkers, Colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 822 participants (actual)
- Lead sponsor
- Creative Biosciences (Guangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Dongguan Shipai Hospital
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 16 May 2022 (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 purpose of this study is to retrospectively analyze colorectal cancer screening data of 40-74 year old population in Shipai Town, Dongguan City.
In this study, the data of SDC2 Gene Methylation Test and Fecal Immunochemistry Test (Q-FIT) were screened from about 11,000 subjects who participated in Colorectal Cancer Screening in Shipai Town People's Livelihood Project from May 2021 to May 2022. Data from 822 subjects with positive SDC2 Gene Methylation Test and/or positive Fecal Immunochemistry Test (Q-FIT) results and with colonoscopy and/or pathological results were selected for retrospective analysis.
This retrospective study evaluated the screening performance of SDC2 Gene Methylation Test and/or Fecal Immunochemistry Test (Q-FIT) for colorectal cancer using colonoscopy and/or pathological results as the clinical standard method.
Detailed description
This study is a retrospective and observational study. Subjects were not be given or offered any treatment during the study. The investigator reviewed the patient's medical history and examination report to determine eligibility based on inclusion and exclusion criteria.
This study retrospectively analyse the basic information and the test results of SDC2 Gene Methylation Test and Fecal Immunochemistry Test (Q-FIT) of about 11,000 subjects who participated in the Colorectal Cancer Screening in Shipai Town People's Livelihood Project from May 2021 to May 2022. A total of 822 subjects with positive SDC2 Gene Methylation Test results and / or positive Fecal Immunochemistry Test (Q-FIT) results were screened out and their colonoscopy results were collected.
822 subjects were classified according to colonoscopy and/or pathological detection results, and the screening performance of the SDC2 Gene Methylation Test and Fecal Immunochemistry Test (Q-FIT) for colorectal cancer was statistically analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects with positive SDC2 Gene Methylation Test | – | Diagnostic Test: SDC2 Gene Methylation Test and Q-FIT Test, Procedure: Colonoscopy and/or pathological examinationSubjects must meet both of the following criteria to be eligible for the study: 1. Subjects with positive SDC2 Gene Methylation Test; 2. Subjects with colonoscopy results and/or pathological results. |
| Subjects with positive Q-FIT Test | – | Diagnostic Test: SDC2 Gene Methylation Test and Q-FIT Test, Procedure: Colonoscopy and/or pathological examinationSubjects must meet both of the following criteria to be eligible for the study: 1. Subjects with positive Q-FIT Test; 2. Subjects with colonoscopy results and/or pathological results. |
| Subjects with positive SDC2 Gene Methylation Test and Q-FIT Test | – | Diagnostic Test: SDC2 Gene Methylation Test and Q-FIT Test, Procedure: Colonoscopy and/or pathological examinationSubjects must meet both of the following criteria to be eligible for the study: 1. Subjects with positive SDC2 Gene Methylation Test and Q-FIT Test; 2. Subjects with colonoscopy results and/or pathological results. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects live in Shipai Town, Dongguan city, the age limit is 40-74 years，822 subjects meet the inclusion criteria for this study.
Key inclusion criteria (3 listed)
- Subjects with positive SDC2 Gene Methylation Test and/or Q-FIT;
- Subjects with colonoscopy and/or pathological results.
Key exclusion criteria (3 listed)
- Data Missing or damaged;
- Unqualified colonoscopy or unqualified stool test.
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 |
|---|---|---|
| SDC2 Gene Methylation Test and Q-FIT TestStool specimens were collected by the subjects for SDC2 Gene Methylation Test and Q-FIT Test | Diagnostic test | Subjects with positive Q-FIT Test, Subjects with positive SDC2 Gene Methylation Test, Subjects with positive SDC2 Gene Methylation Test and Q-FIT Test |
| Colonoscopy and/or pathological examinationSubjects underwent colonoscopy and/or pathological examination. | Procedure or surgery | Subjects with positive Q-FIT Test, Subjects with positive SDC2 Gene Methylation Test, Subjects with positive SDC2 Gene Methylation Test and Q-FIT Test |
Primary outcome
Positive predictive value (PPV)
Time frame: one month
PPV is the number of real positive cases in the total number of stool gene DNA methylation detection positive or/and Q-FIT positive.
Sensitivity
Time frame: one month
Sensitivity is the percentage of subjects with colon cancer who are correctly identified by the testing kit.
Tumor detection rate in the positive screening results
Time frame: one month
Compare to clinical standard method results, the tumor detection rates of the three groups were analyzed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Derived from this study: PubMed 40241850Kong X, Wu Q, Zhang Z, Yu Z, Niu F, Wang X, Zou H. Effectiveness of single-target fecal DNA methylation test in regional mass screening for colorectal cancer and precancerous lesions in China. Gastroenterol Rep (Oxf). 2025 Apr 15;13:goaf029. doi: 10.1093/gastro/goaf029. eCollection 2025.
- Individual participant dataSharing planned: Undecided. We are carefully considering all applicable regulations and laws governing sharing of patients' data from China online with the global public.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Zhi Zhang principal investigator
Dongguan Shipai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Advanced Adenocarcinoma, run by Creative Biosciences (Guangzhou) Co., Ltd. at 1 site 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 3 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: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive predictive value (PPV) (time frame: one month). The study lists 3 primary outcomes in all. 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 NCT05374369, 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 29 Jul 2022.