Colorectal CancerNCT04722055
A Multicenter Clinical Trial of Stool-based DNA Testing for Early Detection of Colon Cancer in China
An observational study of Colorectal Cancer and Advanced Adenocarcinoma, run by Creative Biosciences (Guangzhou) Co., Ltd. at 1 site in China.
Trial summary
According to data from Global Cancer Statistics 2018, colorectal cancer (CRC) ranks second in incidence and fifth in mortality among all cancers in China. The underlying neoplastic progression from adenoma to CRC endures up to 10 years, providing an extended window for CRC detection and screening. Read more about this study
- Who is it for?
- Ages 40 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Advanced Adenocarcinoma, Hyperplastic Polyp
- What is being tested?
- Multigene Methylation Detection Kit
- How many people
- 1,273 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2021to 8 Aug 2022
- How long will I take part?
- 3 Months
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants aged 40-79 years old, regardless of gender or region, and those who meet the inclusion criteria for this clinical trial, are eligible to enroll at the designated clinical sites. Up to 1113 participants will be enrolled.
Who may be able to join
- Participants must also meet the following three criteria to be included in this study:
- To be 40 to 79 years old, regardless of gender;
- To participate voluntarily and sign Informed Consent Form;
- To satisfy any of the following three conditions:
- Patients with colorectal cancer confirmed or suspected by colonoscopy or pathological biopsy;
- Patients with gastrointestinal disease or normal population to be examined by colonoscopy;
- Patients who are planning to undergo colonoscopy or have colonoscopy results from other interfering diseases.
Who cannot join
- Patients with any of the following conditions shall be excluded:
- To have had radical resection of colorectal cancer before enrollment in this study;
- To have been deemed ineligible to participate in the study by the principal investigator due to various other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Clinical Trial of Human Multigene Methylation Detection Kit (Fluorescent PCR)
According to data from Global Cancer Statistics 2018, colorectal cancer (CRC) ranks second in incidence and fifth in mortality among all cancers in China. The underlying neoplastic progression from adenoma to CRC endures up to 10 years, providing an extended window for CRC detection and screening. Currently, fecal occult blood test (FOBT) and colonoscopy are the main diagnostic and screening methods for CRC in Chinese clinical practice. However, due to low patients' compliance with colonoscopy and poor sensitivity of FOBT, a large proportion of CRC could not be effectively diagnosed and treated at early stage. Therefore, noninvasive fecal DNA detection approach with enhanced performance is urgently needed in clinic.
The aim of this trial is to evaluate effectiveness of the Human Multigene Methylation Detection Kit (Fluorescent PCR) for auxiliary diagnosis of colorectal cancer. By assessing the level of DNA methylation of certain genes in human stool, the test can indicate whether cancerous and precancerous lesions exist in the areas of colon and rectum.
Read the detailed description
The multicenter clinical trial will be conducted using a single-blind method. Stool samples provided by participants will be evaluated by Human Multigene Methylation Detection Kit (Fluorescent PCR). The kit will be used to qualitatively detect methylation levels of multiple genes in human stool samples in vitro by using Quantitative Methylation Specific PCR (qMSP). The principle of the method is as follows. First, the target DNA in human stool is extracted by magnetic bead-capture technology and then treated with sodium bisulfite. The sequence of unmethylated DNA will be changed while that of the methylated DNA remains the same after sodium bisulfite treatment. Subsequently, qMSP is employed to detect methylation levels of target genes in addition to ACTB gene (a reference gene). Controls of ACTB gene with and without methylation are tested simultaneously. Result of qMSP is dichotomized as positive and negative based on Ct value obtained. The test result is then verified by Sanger sequencing and compared with that from colonoscopy examination and pathology report. The main evaluation indexes for test performance are sensitivity, specificity, consistency rate, kappa coefficient.
- Conditions
- Colorectal Cancer, Advanced Adenocarcinoma, Hyperplastic Polyp, Colorectal Neoplasms, Digestive System Neoplasm, Neoplasms
- Being tested
- Multigene Methylation Detection Kit
- Keywords
- Colorectal Cancer, Colon Cancer, Stool DNA test, fecal DNA test, 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.
Multigene Methylation Detection KitDiagnostic test
Also called Colosafe 2.0
Eligible participants are required to take stool samples for multigene methylation detection and gene sequencing, undergo colonoscopy examination, and have a biopsy when necessary (gold standard).
| Study group | Role | What they receive |
|---|---|---|
| Study group | Single arm of continuously enrolled participants. All eligible participants will be included in the study according to the inclusion criteria. In addition to giving stool samples for multigene methylation test, eligible participants need to undergo colonoscopy examination and have their biopsies taken when necessary (gold standard). Receives: Diagnostic Test: Multigene Methylation Detection Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity is the true positive fraction of participants with colorectal cancer.
Measured: Two years
Specificity
Specificity is the true negative fraction of participants without colorectal cancer.
Measured: Two years
Consistency rate
Consistency rate is the fraction of both true positive and negative diagnostic test results among all participants.
Measured: Two years
Kappa coefficient
Kappa coefficient is the consistency analysis of the extent of agreement between the test results of Colosafe 2.0 and reference colonoscopy.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start26 Jan 2021
- Primary completion19 Jan 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,273 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Creative Biosciences (Guangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xianrang Song, PhD, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722055
- Sponsor's protocol ID
- KLM2020-02
- Status last verified
- Nov 2011
- First submitted
- 20 Jan 2021
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are carefully considering all applicable regulations and laws governing sharing of patients' data from China online with the global public.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Trial of Human Multigene Methylation Detection Kit (Fluorescent PCR)
- ClinicalTrials.gov ID
- NCT04722055
- Acronym / sponsor ID
- KLM2020-02
- Conditions
- Colorectal Cancer, Advanced Adenocarcinoma, Hyperplastic Polyp, Colorectal Neoplasms, Digestive System Neoplasm, Neoplasms
- Keywords
- Colorectal Cancer, Colon Cancer, Stool DNA test, fecal DNA test, Methylation Biomarkers, Colonoscopy, Cancer Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,273 participants (actual)
- Lead sponsor
- Creative Biosciences (Guangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 25 Jan 2021 (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.
According to data from Global Cancer Statistics 2018, colorectal cancer (CRC) ranks second in incidence and fifth in mortality among all cancers in China. The underlying neoplastic progression from adenoma to CRC endures up to 10 years, providing an extended window for CRC detection and screening. Currently, fecal occult blood test (FOBT) and colonoscopy are the main diagnostic and screening methods for CRC in Chinese clinical practice. However, due to low patients' compliance with colonoscopy and poor sensitivity of FOBT, a large proportion of CRC could not be effectively diagnosed and treated at early stage. Therefore, noninvasive fecal DNA detection approach with enhanced performance is urgently needed in clinic.
The aim of this trial is to evaluate effectiveness of the Human Multigene Methylation Detection Kit (Fluorescent PCR) for auxiliary diagnosis of colorectal cancer. By assessing the level of DNA methylation of certain genes in human stool, the test can indicate whether cancerous and precancerous lesions exist in the areas of colon and rectum.
Detailed description
The multicenter clinical trial will be conducted using a single-blind method. Stool samples provided by participants will be evaluated by Human Multigene Methylation Detection Kit (Fluorescent PCR). The kit will be used to qualitatively detect methylation levels of multiple genes in human stool samples in vitro by using Quantitative Methylation Specific PCR (qMSP). The principle of the method is as follows. First, the target DNA in human stool is extracted by magnetic bead-capture technology and then treated with sodium bisulfite. The sequence of unmethylated DNA will be changed while that of the methylated DNA remains the same after sodium bisulfite treatment. Subsequently, qMSP is employed to detect methylation levels of target genes in addition to ACTB gene (a reference gene). Controls of ACTB gene with and without methylation are tested simultaneously. Result of qMSP is dichotomized as positive and negative based on Ct value obtained. The test result is then verified by Sanger sequencing and compared with that from colonoscopy examination and pathology report. The main evaluation indexes for test performance are sensitivity, specificity, consistency rate, kappa coefficient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Multigene Methylation Detection KitSingle arm of continuously enrolled participants. All eligible participants will be included in the study according to the inclusion criteria. In addition to giving stool samples for multigene methylation test, eligible participants need to undergo colonoscopy examination and have their biopsies taken when necessary (gold standard). |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants aged 40-79 years old, regardless of gender or region, and those who meet the inclusion criteria for this clinical trial, are eligible to enroll at the designated clinical sites. Up to 1113 participants will be enrolled.
Key inclusion criteria (7 listed)
- Participants must also meet the following three criteria to be included in this study:
Key exclusion criteria (3 listed)
- Patients with any of the following conditions shall be excluded:
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 |
|---|---|---|
| Multigene Methylation Detection KitAlso: Colosafe 2.0Eligible participants are required to take stool samples for multigene methylation detection and gene sequencing, undergo colonoscopy examination, and have a biopsy when necessary (gold standard). | Diagnostic test | Study group |
Primary outcome
Sensitivity
Time frame: Two years
Sensitivity is the true positive fraction of participants with colorectal cancer.
Specificity
Time frame: Two years
Specificity is the true negative fraction of participants without colorectal cancer.
Consistency rate
Time frame: Two years
Consistency rate is the fraction of both true positive and negative diagnostic test results among all participants.
Kappa coefficient
Time frame: Two years
Kappa coefficient is the consistency analysis of the extent of agreement between the test results of Colosafe 2.0 and reference colonoscopy.
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 21 Oct 2022.
- Individual participant dataSharing planned: No. We are carefully considering all applicable regulations and laws governing sharing of patients' data from China online with the global public.
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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.
Xianrang Song, PhD principal investigator
Shandong Cancer Hospital and Institute
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 7 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 21 Oct 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?
Sensitivity (time frame: Two years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2022.