Colorectal CancerNCT04913233
Establishment and Clinical Validation of New Technologies for Accurate Screening of Colorectal Cancer Based on Multi-omics
An observational study of Colorectal Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.
Trial summary
Background: The current screening techniques for colorectal cancer include colonoscopy, fecal occult blood, and high-risk factor questionnaires. However, the colorectal cancer screening technology that has been widely used at present cannot take into account sensitivity and specificity, and the tumor detection rate is… Read more about this study
- Who is it for?
- Ages 40 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- How many people
- 9,000 participants
- Where
- 3 sitesChina
- Study dates
- Jul 2021to Nov 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals of 40-74 years old in non-high incidence of colorectal cancer areas(hospital outpatient population, community population in non-high-risk areas) .
Who may be able to join
- Age: 40-74 years old
Who cannot join
- Combine severe disorders to make it unsuitable for colonoscopy
- Combine other tumors
- Mental and behavioral abnormalities do not cooperate with the screener
- Researchers believe that other reasons are not suitable for enrollment
Trial locations and contacts
3 sites in 1 country.
China3 sites
Chinese Medicine Hospital of Haining City, Haining Cancer Preventional and Treatment Research Institute
Haining, Zhejiang, 314400
Weihua Ma, 672682815@qq.com
Jiashan County Cancer Prevention and Treatment Institute
Jiashan, Zhejiang, 314100
Xinglin Fei, feixl711@163.com
Lanxi City People's Hospital, Linjiang Hospital
Lanxi, Zhejiang, 321100
Weifang Zheng, 2609276435@qq.com
About this study
Official title: Research on New Technologies for Screening and Early Diagnosis of Malignant Tumors - Establishment and Clinical Validation of New Technologies for Accurate Screening of Colorectal Cancer Based on Multi-omics
Background:
The current screening techniques for colorectal cancer include colonoscopy, fecal occult blood, and high-risk factor questionnaires. However, the colorectal cancer screening technology that has been widely used at present cannot take into account sensitivity and specificity, and the tumor detection rate is low.
The purpose of research:
- Build a new type of population colorectal cancer precision screening technology program;
- Improve the detection rate of colorectal cancer in the population by new methods (compared with the existing domestic advanced technology) by ≥20%, and improve the specificity of colorectal cancer screening by ≥15% without significantly reducing the sensitivity.
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Cancer Screening, Colonoscopy, APCS, HRFQ
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer detection rate in the population
Colorectal cancer detection rate in the population
Measured: through study completion, an average of 3 years
Colorectal cancer screening specificity
Colorectal cancer screening specificity
Measured: through study completion, an average of 3 years
Colorectal cancer screening sensitivity
Colorectal cancer screening sensitivity
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study startJul 2021 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionNov 2024 (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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 9,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913233
- Sponsor's protocol ID
- 2021-0199
- Status last verified
- May 2021
- First submitted
- 30 May 2021
- Last updated
- 4 Jun 2021
- 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 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on New Technologies for Screening and Early Diagnosis of Malignant Tumors - Establishment and Clinical Validation of New Technologies for Accurate Screening of Colorectal Cancer Based on Multi-omics
- ClinicalTrials.gov ID
- NCT04913233
- Acronym / sponsor ID
- 2021-0199
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Cancer Screening, Colonoscopy, APCS, HRFQ
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 4 Jun 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.
Background:
The current screening techniques for colorectal cancer include colonoscopy, fecal occult blood, and high-risk factor questionnaires. However, the colorectal cancer screening technology that has been widely used at present cannot take into account sensitivity and specificity, and the tumor detection rate is low.
The purpose of research:
- Build a new type of population colorectal cancer precision screening technology program;
- Improve the detection rate of colorectal cancer in the population by new methods (compared with the existing domestic advanced technology) by ≥20%, and improve the specificity of colorectal cancer screening by ≥15% without significantly reducing the sensitivity.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals of 40-74 years old in non-high incidence of colorectal cancer areas(hospital outpatient population, community population in non-high-risk areas) .
Key inclusion criteria (1 listed)
- Age: 40-74 years old
Key exclusion criteria (4 listed)
- Combine severe disorders to make it unsuitable for colonoscopy
- Combine other tumors
- Mental and behavioral abnormalities do not cooperate with the screener
- Researchers believe that other reasons are not suitable for enrollment
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
Colorectal cancer detection rate in the population
Time frame: through study completion, an average of 3 years
Colorectal cancer detection rate in the population
Colorectal cancer screening specificity
Time frame: through study completion, an average of 3 years
Colorectal cancer screening specificity
Colorectal cancer screening sensitivity
Time frame: through study completion, an average of 3 years
Colorectal cancer screening sensitivity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
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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.
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, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 inclusion and 4 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 4 Jun 2021. 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 Ying Yuan (+8613858193601, yuanying1999@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal cancer detection rate in the population (time frame: through study completion, an average of 3 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 4 Jun 2021.