Colorectal CancerNCT07090291
China Colorectal Cancer Screening Trial 1 (C-Cost1)
A study testing Colonoscopy, FIT and Blood test in people with Colorectal Cancer and Advanced Adenoma, run by Zhejiang University at 7 sites in China.
Trial summary
Colorectal cancer (CRC) is one of the most common malignancies in China. Currently, its incidence rate is increasing at a rate of 4% per year, exceeding the global annual average growth rate. Read more about this study
- Who is it for?
- Ages 45 to 74 years
- Conditions the study is for
- Colorectal Cancer, Advanced Adenoma
- What is being tested?
- Colonoscopy, FIT and Blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60,300 participants
- Where
- 7 sitesChina
- Study dates
- 8 Aug 2025to Jul 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 45-74 years old;
- In good general condition, with normal mental state and voluntarily signing the informed consent form;
Who cannot join
- Personal history of colorectal cancer or precancerous lesions;
- History of previous colonrectal resection surgery;
- Diagnosed with cancer before enrollment or currently receiving any cancer-related treatment;
- Having received colonoscopy, flexible sigmoidoscopy, CT colonography and other examinations within the past 5 years;
- Having received FIT or FIT-sDNA or cfDNA test within the past 1 year;
- Symptomatic lower gastrointestinal diseases or symptoms suggesting the need for diagnostic colonoscopy for confirmation;
- Accompanied by severe diseases that are not suitable for colorectal cancer screening;
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guandong
Yanping Fan
- Recruiting
Maoming People's Hospital
Guangdong
Yisheng Huang
- Recruiting
The Fourth Hospital of Hebei Medical University
Hebei
Limian Er, hbsyelm@163.com
- Recruiting
Nanjing Medical University
Nanjing
Dong Hang, hangdong@njmu.edu.cn
- Recruiting
Shanghai Municipal Center For Disease Control & Prevention
Shanghai
Kai Gu
- Recruiting
Sichuan Cancer Hospital & Institute, Sichuan Cancer Center
Sichuan
Liang Qiao
- Recruiting
Zhejiang Provincial Center for Disease Control and Prevention
Zhejiang
Lingbin Du
About this study
Official title: China Colorectal Cancer Screening Trial 1 (C-Cost1): Colonoscopy Versus FIT Versus FIT Plus Blood Test in the Average Risk Population
Colorectal cancer (CRC) is one of the most common malignancies in China. Currently, its incidence rate is increasing at a rate of 4% per year, exceeding the global annual average growth rate. Screening and early diagnosis of colorectal cancer and precancerous lesions are key measures to reduce the disease burden of colorectal cancer in China. In previous clinical studies, colorectal cancer screening in high risk population received extensive attention. However, it cannot be ignored that the majority of sporadic colorectal cancers occur in the average risk population. Therefore, there is an urgent need to develop new approach for colorectal cancer screening in the average risk population in China.
Fecal Immunochemical Testing (FIT) initial screening followed by diagnostic colonoscopy is widely recommended by colorectal cancer screening guidelines worldwide. The current colorectal cancer screening approach faces challenges including limited sensitivity of initial screening technologies and insufficient population coverage in organized screening programs in China. As initial screening technologies, non-invasive blood tests which detects cfDNA methylation have been reported to have higher accuracy than FIT in detecting colorectal cancer. However, There is a lack of randomized controlled trials (RCTs) comparing the effectiveness of colonoscopy, FIT and FIT plus blood test for colorectal cancer screening.
In China Colorectal Cancer Screening Trial 1 (C-Cost1), we propose to perform a multicenter, cluster randomized, parallel group trial directly comparing colonoscopy with FIT and with FIT plus blood test in the average risk population in China. The main research hypotheses are: (1) The screening protocol of FIT group (Group B) is non-inferior to the colonoscopy group (Group A) in the colorectal cancer mortality rate at 10 years; (2) The screening protocol of FIT plus blood test group (Group C) is non-inferior to the colonoscopy group (Group A) in the colorectal cancer mortality rate at 10 years. Both of the two hypotheses should be met.
Read the detailed description
This study intends to recruit participants who meet the above inclusion and exclusion criteria in China, with the goal of recruiting at least 60300 eligible participants at baseline. The study adopts a cluster randomized controlled design. After signing the informed consent form, eligible participants will be randomly assigned to 3 colorectal cancer screening groups. All participants will undergo a 4-year screening phase, and then all participants will be followed up for a long term. Fecal, blood, and tissue samples will be collected from the participants during the study. The grouping and specific intervention measures are as follows:
- Colonoscopy group (n = 20100): The internationally recommended screening protocol is adopted. The participants will only undergo a colonoscopy once at the first year. Suspicious lesions detected during the colonoscopy will be resected and further sent for pathological examination. All the participants will then receive annual follow-ups for the next 3 years, followed by long-term follow-ups.
- FIT group (n = 20100): The internationally recommended screening protocol is adopted. In the first 4 years of the screening phase, all participants will receive annual FIT tests. Participants with positive FIT results are recommended to undergo diagnostic colonoscopy. Suspicious lesions detected during the colonoscopy will be resected and further sent for pathological examination. Participants who refuse FIT tests, have negative FIT tests, have positive FIT tests but do not receive diagnostic colonoscopy will be screened again in the first 4 years. All the participants will be followed by long-term follow-ups.
- FIT plus blood test group (n = 20100): A new screening protocol is adopted. In the first 4 years of the screening phase, all participants will receive annual FIT tests and blood tests. Participants with positive FIT tests or positive blood tests are recommended to undergo diagnostic colonoscopy. Suspicious lesions detected during the colonoscopy will be resected and further sent for pathological examination. Participants who refuse FIT plus blood tests, have negative FIT plus blood tests, have positive FIT tests or positive blood tests but do not receive diagnostic colonoscopy will be screened again in the first 4 years. All the participants will be followed by long-term follow-ups.
- Conditions
- Colorectal Cancer, Advanced Adenoma
- Being tested
- Colonoscopy, FIT, Blood test
- Keywords
- FIT; FIT plus blood test; cfDNA methylation; Colorectal cancer; Advanced colorectal adenoma; Early screening; Average risk population
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyDiagnostic test
Colonoscopy is used to examine the inner lining of the colon and rectum. During the procedure, if suspicious growths (e.g., polyps) are detected, they will be biopsied and sent for pathological examination.
FITDiagnostic test
FIT stands for Fecal Immunochemical Test, a non-invasive screening tool used primarily to detect hidden blood in the stool, which may indicate colorectal cancer or precancerous polyps. Positive cut-off level: 100 ng/mL.
Blood testDiagnostic test
Blood test based on cfDNA methylation will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy group | Active comparator | The internationally recommended screening protocol is adopted. The participants will only undergo a colonoscopy once at the first year. Suspicious lesions detected during the colonoscopy will be resected and further sent for pathological examination. All the participants will then receive annual follow-ups for the next 3 years, followed by long-term follow-ups. Receives: Diagnostic Test: Colonoscopy |
| FIT group | Active comparator | The internationally recommended screening protocol is adopted. In the first 4 years of the screening phase, all participants will receive annual FIT tests. Participants with positive FIT results are recommended to undergo diagnostic colonoscopy. Suspicious lesions detected during the colonoscopy will be resected and further sent for pathological examination. Participants who refuse FIT tests, have negative FIT tests, have positive FIT tests but do not receive diagnostic colonoscopy will be screened again in the first 4 years. All the participants will be followed by long-term follow-ups. Receives: Diagnostic Test: FIT |
| FIT plus blood test group | Experimental | A new screening protocol is adopted. In the first 4 years of the screening phase, all participants will receive annual FIT tests and blood tests. Participants with positive FIT tests or positive blood tests are recommended to undergo diagnostic colonoscopy. Suspicious lesions detected during the colonoscopy will be resected and further sent for pathological examination. Participants who refuse FIT plus blood tests, have negative FIT plus blood tests, have positive FIT tests or positive blood tests but do not receive diagnostic colonoscopy will be screened again in the first 4 years. All the participants will be followed by long-term follow-ups. Receives: Diagnostic Test: FIT; Diagnostic Test: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate of colorectal cancer
Mortality rate of colorectal cancer
Measured: 10 years
Secondary outcomes (7)
Detection rate of advanced colorectal neoplasms
Advanced colorectal neoplasms includes advanced adenomas and colorectal cancer
Measured: 4 years
Population compliance rate
Population compliance rate
Measured: 4 years
Proportion of colorectal cancer at different stages
Proportion of colorectal cancer at different stages
Measured: 4 years
Incidence rate of colorectal cancer
Incidence rate of colorectal cancer
Measured: 10 years
Quality of life (QOL)
Quality of life will be assessed by EuroQol five-dimensional questionnaire (EQ-5D）
Measured: 4 years
Total cost and cost per detected lesion
Total cost and cost per detected lesion
Measured: 4 years
Incremental cost-effectiveness ratio
Incremental cost-effectiveness ratio
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start8 Aug 2025
- Primary completionJul 2035 (estimated)
- Study completionJul 2035 (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 Zhejiang 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Ke-Feng, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090291
- Sponsor's protocol ID
- C-Cost1
- Status last verified
- Apr 2026
- First submitted
- 20 Jul 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Colorectal Cancer Screening Trial 1 (C-Cost1): Colonoscopy Versus FIT Versus FIT Plus Blood Test in the Average Risk Population
- ClinicalTrials.gov ID
- NCT07090291
- Acronym / sponsor ID
- C-Cost1
- Conditions
- Colorectal Cancer, Advanced Adenoma
- Keywords
- FIT; FIT plus blood test; cfDNA methylation; Colorectal cancer; Advanced colorectal adenoma; Early screening; Average risk population
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60,300 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- Jul 2035 (estimated)
- Study completion
- Jul 2035 (estimated)
- First posted
- 29 Jul 2025 (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.
Colorectal cancer (CRC) is one of the most common malignancies in China. Currently, its incidence rate is increasing at a rate of 4% per year, exceeding the global annual average growth rate. Screening and early diagnosis of colorectal cancer and precancerous lesions are key measures to reduce the disease burden of colorectal cancer in China. In previous clinical studies, colorectal cancer screening in high risk population received extensive attention. However, it cannot be ignored that the majority of sporadic colorectal cancers occur in the average risk population. Therefore, there is an urgent need to develop new approach for colorectal cancer screening in the average risk population in China.
Fecal Immunochemical Testing (FIT) initial screening followed by diagnostic colonoscopy is widely recommended by colorectal cancer screening guidelines worldwide. The current colorectal cancer screening approach faces challenges including limited sensitivity of initial screening technologies and insufficient population coverage in organized screening programs in China. As initial screening technologies, non-invasive blood tests which detects cfDNA methylation have been reported to have higher accuracy than FIT in detecting colorectal cancer. However, There is a lack of randomized controlled trials (RCTs) comparing the effectiveness of colonoscopy, FIT and FIT plus blood test for colorectal cancer screening.
In China Colorectal Cancer Screening Trial 1 (C-Cost1), we propose to perform a multicenter, cluster randomized, parallel group trial directly comparing colonoscopy with FIT and with FIT plus blood test in the average risk population in China. The main research hypotheses are: (1) The screening protocol of FIT group (Group B) is non-inferior to the colonoscopy group (Group A) in the colorectal cancer mortality rate at 10 years; (2) The screening protocol of FIT plus blood test group (Group C) is non-inferior to the colonoscopy group (Group A) in the colorectal cancer mortality rate at 10 years. Both of the two hypotheses should be met.
Detailed description
This study intends to recruit participants who meet the above inclusion and exclusion criteria in China, with the goal of recruiting at least 60300 eligible participants at baseline. The study adopts a cluster randomized controlled design. After signing the informed consent form, eligible participants will be randomly assigned to 3 colorectal cancer screening groups. All participants will undergo a 4-year screening phase, and then all participants will be followed up for a long term. Fecal, blood, and tissue samples will be collected from the participants during the study. The grouping and specific intervention measures are as follows:
- Colonoscopy group (n = 20100): The internationally recommended screening protocol is adopted. The participants will only undergo a colonoscopy once at the first year. Suspicious lesions detected during the colonoscopy will be resected and further sent for pathological examination. All the participants will then receive annual follow-ups for the next 3 years, followed by long-term follow-ups.
- FIT group (n = 20100): The internationally recommended screening protocol is adopted. In the first 4 years of the screening phase, all participants will receive annual FIT tests. Participants with positive FIT results are recommended to undergo diagnostic colonoscopy. Suspicious lesions detected during the colonoscopy will be resected and further sent for pathological examination. Participants who refuse FIT tests, have negative FIT tests, have positive FIT tests but do not receive diagnostic colonoscopy will be screened again in the first 4 years. All the participants will be followed by long-term follow-ups.
- FIT plus blood test group (n = 20100): A new screening protocol is adopted. In the first 4 years of the screening phase, all participants will receive annual FIT tests and blood tests. Participants with positive FIT tests or positive blood tests are recommended to undergo diagnostic colonoscopy. Suspicious lesions detected during the colonoscopy will be resected and further sent for pathological examination. Participants who refuse FIT plus blood tests, have negative FIT plus blood tests, have positive FIT tests or positive blood tests but do not receive diagnostic colonoscopy will be screened again in the first 4 years. All the participants will be followed by long-term follow-ups.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy group | Active comparator | Diagnostic Test: ColonoscopyThe internationally recommended screening protocol is adopted. The participants will only undergo a colonoscopy once at the first year. Suspicious lesions detected during the colonoscopy will be resected and further sent for pathological examination. All the participants will then receive annual follow-ups for the next 3 years, followed by long-term follow-ups. |
| FIT group | Active comparator | Diagnostic Test: FITThe internationally recommended screening protocol is adopted. In the first 4 years of the screening phase, all participants will receive annual FIT tests. Participants with positive FIT results are recommended to undergo diagnostic colonoscopy. Suspicious lesions detected during the colonoscopy will be resected and further sent for pathological examination. Participants who refuse FIT tests, have negative FIT tests, have positive FIT tests but do not receive diagnostic colonoscopy will be screened again in the first 4 years. All the participants will be followed by long-term follow-ups. |
| FIT plus blood test group | Experimental | Diagnostic Test: FIT, Diagnostic Test: Blood testA new screening protocol is adopted. In the first 4 years of the screening phase, all participants will receive annual FIT tests and blood tests. Participants with positive FIT tests or positive blood tests are recommended to undergo diagnostic colonoscopy. Suspicious lesions detected during the colonoscopy will be resected and further sent for pathological examination. Participants who refuse FIT plus blood tests, have negative FIT plus blood tests, have positive FIT tests or positive blood tests but do not receive diagnostic colonoscopy will be screened again in the first 4 years. All the participants will be followed by long-term follow-ups. |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 45-74 years old;
- In good general condition, with normal mental state and voluntarily signing the informed consent form;
Key exclusion criteria (7 listed)
- Personal history of colorectal cancer or precancerous lesions;
- History of previous colonrectal resection surgery;
- Diagnosed with cancer before enrollment or currently receiving any cancer-related treatment;
- Having received colonoscopy, flexible sigmoidoscopy, CT colonography and other examinations within the past 5 years;
- Having received FIT or FIT-sDNA or cfDNA test within the past 1 year;
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 |
|---|---|---|
| ColonoscopyColonoscopy is used to examine the inner lining of the colon and rectum. During the procedure, if suspicious growths (e.g., polyps) are detected, they will be biopsied and sent for pathological examination. | Diagnostic test | Colonoscopy group |
| FITFIT stands for Fecal Immunochemical Test, a non-invasive screening tool used primarily to detect hidden blood in the stool, which may indicate colorectal cancer or precancerous polyps. Positive cut-off level: 100 ng/mL. | Diagnostic test | FIT group, FIT plus blood test group |
| Blood testBlood test based on cfDNA methylation will be performed. | Diagnostic test | FIT plus blood test group |
Primary outcome
Mortality rate of colorectal cancer
Time frame: 10 years
Mortality rate of colorectal cancer
7 secondary outcomes
Detection rate of advanced colorectal neoplasms
Time frame: 4 years
Population compliance rate
Time frame: 4 years
Proportion of colorectal cancer at different stages
Time frame: 4 years
Incidence rate of colorectal cancer
Time frame: 10 years
Quality of life (QOL)
Time frame: 4 years
Total cost and cost per detected lesion
Time frame: 4 years
Incremental cost-effectiveness ratio
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy, FIT and Blood test in people with Colorectal Cancer and Advanced Adenoma, run by Zhejiang University at 7 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 7 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: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kefeng Ding, MD (86-571-87784827, dingkefeng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate of colorectal cancer (time frame: 10 years). 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 14 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.