Colorectal CancerMETHOD-3NCT05638243
Evaluation of a Model for the Early Diagnosis of Colorectal Cancer by the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA to the Community Colorectal Cancer Screening Program
An observational study of Colorectal Cancer and Colorectal Neoplasms, run by Fudan University at 1 site in China.
Trial summary
The incidence rate and mortality of colorectal cancer are increasing year by year. Most colorectal cancer develops from colorectal adenoma and is a disease that can be prevented and controlled. Thanks to early screening, the incidence rate and mortality of colorectal cancer have declined year by year. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Neoplasms
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2022to Sep 2025
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of Xuhui District, Shanghai, who are initially screened as high-risk for colorectal cancer by Shanghai Xuhui District Center for Disease Control and Prevention, and do not receive a colonoscopy. People who are willing to accept the screening program.
Who may be able to join
- Age ≥ 50 years old and<75 years old;
- The initial screening was positive (fecal occult blood or colorectal cancer risk questionnaire was positive)； ③ Receive sample collection; ④ Sign the informed consent form.
Who cannot join
- ① History of colorectal cancer, colorectal adenoma, and treatment;
- Enteroscopy was performed after the initial screening was positive; ③ The subject or family members could not understand the conditions and objectives of the study or refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Community Health Centers in Xuhui District
Shanghai, Shanghai Municipality, 200032
Donghao Xu, M.D., +86 17621317456, xdh1225@yeah.net
About this study
Official title: Evaluation of a Model for the Early Diagnosis of Colorectal Cancer by the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA to the Community Colorectal Cancer Screening Program in Xuhui District, Shanghai
The incidence rate and mortality of colorectal cancer are increasing year by year. Most colorectal cancer develops from colorectal adenoma and is a disease that can be prevented and controlled. Thanks to early screening, the incidence rate and mortality of colorectal cancer have declined year by year. However, due to poor compliance with colonoscopy and the lack of efficient and convenient early screening methods, it is difficult to screen for colorectal cancer in China. According to the data from Shanghai Xuhui District Center for Disease Control and Prevention, the proportion of colonoscopies in high-risk groups for colorectal cancer is less than 18%.
This project plans to use the latest colorectal cancer screening technology, namely, 5hmC detection in peripheral blood and DNA methylation detection in feces, for those who are positive in the colorectal cancer incidence risk questionnaire or fecal occult blood in Xuhui District, Shanghai. It is strongly recommended that subjects with positive screening should undergo colonoscopy, to effectively improve the rate of colonoscopy and the early diagnosis rate of colorectal cancer. At the same time, to explore the screening efficiency of the early diagnosis model of 5hmC cancer.
- Conditions
- Colorectal Cancer, Colorectal Neoplasms
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High-risk residents | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects receiving colonoscopy
Proportion of subjects receiving colonoscopy
Measured: Three years
Proportion of subjects suffering early colorectal cancer
Proportion of stageⅠcancer in total colorectal cancer
Measured: Three years
Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma
Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start20 Aug 2022
- Primary completionFeb 2025 (estimated)
- Study completionSep 2025 (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 Fudan 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
- Investigators
- Jianmin Xu, M.D.， PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638243
- Sponsor's protocol ID
- METHOD-3
- Acronym
- METHOD-3
- Status last verified
- Nov 2022
- First submitted
- 26 Nov 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Model for the Early Diagnosis of Colorectal Cancer by the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA to the Community Colorectal Cancer Screening Program in Xuhui District, Shanghai
- ClinicalTrials.gov ID
- NCT05638243
- Acronym / sponsor ID
- METHOD-3 / METHOD-3
- Conditions
- Colorectal Cancer, Colorectal Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 6 Dec 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 incidence rate and mortality of colorectal cancer are increasing year by year. Most colorectal cancer develops from colorectal adenoma and is a disease that can be prevented and controlled. Thanks to early screening, the incidence rate and mortality of colorectal cancer have declined year by year. However, due to poor compliance with colonoscopy and the lack of efficient and convenient early screening methods, it is difficult to screen for colorectal cancer in China. According to the data from Shanghai Xuhui District Center for Disease Control and Prevention, the proportion of colonoscopies in high-risk groups for colorectal cancer is less than 18%.
This project plans to use the latest colorectal cancer screening technology, namely, 5hmC detection in peripheral blood and DNA methylation detection in feces, for those who are positive in the colorectal cancer incidence risk questionnaire or fecal occult blood in Xuhui District, Shanghai. It is strongly recommended that subjects with positive screening should undergo colonoscopy, to effectively improve the rate of colonoscopy and the early diagnosis rate of colorectal cancer. At the same time, to explore the screening efficiency of the early diagnosis model of 5hmC cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-risk residents | – | – |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of Xuhui District, Shanghai, who are initially screened as high-risk for colorectal cancer by Shanghai Xuhui District Center for Disease Control and Prevention, and do not receive a colonoscopy. People who are willing to accept the screening program.
Key inclusion criteria (2 listed)
- Age ≥ 50 years old and<75 years old;
Key exclusion criteria (2 listed)
- ① History of colorectal cancer, colorectal adenoma, and treatment;
- Enteroscopy was performed after the initial screening was positive; ③ The subject or family members could not understand the conditions and objectives of the study or refused to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of subjects receiving colonoscopy
Time frame: Three years
Proportion of subjects receiving colonoscopy
Proportion of subjects suffering early colorectal cancer
Time frame: Three years
Proportion of stageⅠcancer in total colorectal cancer
Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma
Time frame: Three years
Sensitivity and specificity of the model in the diagnosis of colorectal cancer and adenoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 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.
Jianmin Xu, M.D.， PhD principal investigator
Fudan University
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 Colorectal Neoplasms, run by Fudan University 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 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 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donghao Xu, M.D. (+86 17621317456, xdh1225@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects receiving colonoscopy (time frame: Three years). 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?
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 Dec 2022.