Colorectal CancerNCT03411707
Multiple Screening Methods for the Detection of Chinese Colorectal Advanced Adenomatous Polyps and Cancer
An observational study of Colorectal Cancer and Colorectal Adenomatous Polyp, run by Sixth Affiliated Hospital, Sun Yat-sen University at 3 sites in China.
Trial summary
The primary objective is to determine the sensitivity and specificity of two Colorectal Cancer (CRC) screening methods, including stool DNA test and blood mRNA test, for colorectal cancer in Chinese population, with colonoscopy as reference method. 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
- What is being tested?
- Stool DNA test
- How many people
- 1,200 participants
- Where
- 3 sitesChina
- Study dates
- 19 Mar 2018to Jun 2023
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants at high risk of developing colorectal cancer.
Who may be able to join
- Subjects received screening questionnaire and had been defined as high risk.
- Subjects haven't received any treatment under colonoscopy within 10 years.
Who cannot join
- Subjects are under the usage of specific drugs which might affect the screening test.
- Subjects had the contraindication for colonoscopy.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
The Sixth Affiliated Hospital, Sun Yet-sen University
Guangzhou
Ping Lan, MD, PhD
- Recruiting
Changhai Hospital
Shanghai
Enda Yu, MBBS
- Recruiting
Tianjin Nankai Hospital
Tianjin
Ximo Wang, MD, PhD
About this study
Official title: A Multicenter Clinical Trial for the Comparison Among Fecal Immunochemical Test, Stool DNA Test and Blood mRNA Test in Chinese Colorectal Cancer Screening
The primary objective is to determine the sensitivity and specificity of two Colorectal Cancer (CRC) screening methods, including stool DNA test and blood mRNA test, for colorectal cancer in Chinese population, with colonoscopy as reference method. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
The secondary objective is to compare the performance of these two CRC screening methods to a commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
Read the detailed description
Participants who are at high risk of developing colorectal cancer will be asked to collect two stool samples one for the stool DNA test and the other for the commercially available FIT assay, and a single blood sample for the blood mRNA test. Subjects will undergo colonoscopy within 6 months of enrollment. 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
- Being tested
- Stool DNA test
- Keywords
- Colorectal cancer screening, Stool DNA test, Blood mRNA 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 DNA testDiagnostic test
Also called Blood mRNA test, FIT Assay
Stool DNA test could detect specific gene methylation in stool DNA. Blood mRNA test could detect specific set of gene expression in blood.
| Study group | Role | What they receive |
|---|---|---|
| Mutiple screening test group | Not described Receives: Diagnostic Test: Stool DNA test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of Multiple Screening Methods With Comparison to Colonoscopy, Both With Respect to Cancer.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start19 Mar 2018
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
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.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, Tianjin Nankai Hospital
- Responsible party
- Principal investigator, Hongzhi Zou, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Hongzhi Zou, MD, PhD, Principal investigator, The Sixth Affiliated Hospital, Sun Yet-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411707
- Sponsor's protocol ID
- SC2017
- Status last verified
- May 2022
- First submitted
- 20 Jan 2018
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Trial for the Comparison Among Fecal Immunochemical Test, Stool DNA Test and Blood mRNA Test in Chinese Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT03411707
- Acronym / sponsor ID
- SC2017
- Conditions
- Colorectal Cancer, Colorectal Adenomatous Polyp
- Keywords
- Colorectal cancer screening, Stool DNA test, Blood mRNA test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Changhai Hospital, Tianjin Nankai Hospital
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 26 Jan 2018 (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 determine the sensitivity and specificity of two Colorectal Cancer (CRC) screening methods, including stool DNA test and blood mRNA test, for colorectal cancer in Chinese population, with colonoscopy as reference method. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
The secondary objective is to compare the performance of these two CRC screening methods to a commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
Detailed description
Participants who are at high risk of developing colorectal cancer will be asked to collect two stool samples one for the stool DNA test and the other for the commercially available FIT assay, and a single blood sample for the blood mRNA test. Subjects will undergo colonoscopy within 6 months of enrollment. 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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mutiple screening test group | – | Diagnostic Test: Stool DNA test |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants at high risk of developing colorectal cancer.
Key inclusion criteria (2 listed)
- Subjects received screening questionnaire and had been defined as high risk.
- Subjects haven't received any treatment under colonoscopy within 10 years.
Key exclusion criteria (2 listed)
- Subjects are under the usage of specific drugs which might affect the screening test.
- Subjects had the contraindication for colonoscopy.
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 DNA testAlso: Blood mRNA test, FIT AssayStool DNA test could detect specific gene methylation in stool DNA. Blood mRNA test could detect specific set of gene expression in blood. | Diagnostic test | Mutiple screening test group |
Primary outcome
Sensitivity and Specificity of Multiple Screening Methods With Comparison to Colonoscopy, Both With Respect to Cancer.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
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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.
Hongzhi Zou, MD, PhD principal investigator
The Sixth Affiliated Hospital, Sun Yet-sen University
3 sites 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 Colorectal Adenomatous Polyp, run by Sixth Affiliated Hospital, Sun Yat-sen University at 3 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 2 inclusion and 2 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 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Hongzhi Zou, MD, PhD (86-020-82510982, zouhongzhi@creativebio.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of Multiple Screening Methods With Comparison to Colonoscopy, Both With Respect to Cancer. (time frame: 6 months). 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 6 May 2022.