Colorectal CancerNCT07090304
China Colorectal Cancer Screening Trial 2 (C-Cost2)
A study testing FIT and FIT-sDNA in people with Colorectal Cancer and Advanced Adenoma, run by Zhejiang University.
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?
- FIT and FIT-sDNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,504 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Nov 2028
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: China Colorectal Cancer Screening Trial 2 (C-Cost2): FIT Versus FIT-sDNA 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. Stool DNA tests detect DNA biomarkers of tumor cells in the stool and have higher sensitivity in detecting advanced colorectal neoplasms. USPSTF has recommended FIT-sDNA as initial screening tests in the average risk population. Colorectal Cancer Early Screening in China (Clear-C) trial has reported FIT-sDNA had higher sensitivity than FIT in detecting advanced colorectal neoplasms among high risk population, yet there is a lack of randomized controlled trials (RCTs) directly comparing the effectiveness of FIT and FIT-sDNA for colorectal cancer screening in the average risk population in China.
In China Colorectal Cancer Screening Trial 2 (C-Cost2), we propose to perform a multicenter, individual-level randomized, parallel group trial directly comparing FIT and FIT-sDNA in the average risk population in China. The main research hypothesis is that the screening protocol of FIT-sDNA group (Group B) has a superior detection rate of advanced colorectal neoplasms compared to the FIT group (Group A).
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 7504 eligible participants at baseline. The study adopts an individual-level randomized design. After signing the informed consent form, eligible participants will be randomly assigned to 2 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:
- FIT group (n = 3752): 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-sDNA group (n = 3752): A new screening protocol is adopted. In the first 4 years of the screening phase, all participants will receive annual FIT-sDNA tests. Participants with positive FIT-sDNA 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-sDNA tests, have negative FIT-sDNA tests, have positive FIT-sDNA 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
- FIT, FIT-sDNA
- Keywords
- FIT; FIT-sDNA; 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.
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.
FIT-sDNADiagnostic test
FIT-sDNA test combines Fecal Immunochemical Test (FIT) and stool DNA (sDNA) analysis. It detects hemoglobin in stool through FIT to identify occult blood in the gastrointestinal tract and simultaneously analyzes specific DNA mutations or epigenetic alterations (such as methylation changes) in stool DNA to assess the risk of colorectal neoplasms.
| Study group | Role | What they receive |
|---|---|---|
| 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-sDNA group | Experimental | A new screening protocol is adopted. In the first 4 years of the screening phase, all participants will receive annual FIT-sDNA tests. Participants with positive FIT-sDNA 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-sDNA tests, have negative FIT-sDNA tests, have positive FIT-sDNA 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-sDNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of advanced colorectal neoplasms
Advanced colorectal neoplasms includes advanced adenomas and colorectal cancer
Measured: 4 years
Secondary outcomes (7)
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
Mortality rate of colorectal cancer
Mortality 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 startJul 2025 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (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
- 7,504 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
- NCT07090304
- Sponsor's protocol ID
- C-Cost2
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 29 Jul 2025
- 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 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Colorectal Cancer Screening Trial 2 (C-Cost2): FIT Versus FIT-sDNA in the Average Risk Population
- ClinicalTrials.gov ID
- NCT07090304
- Acronym / sponsor ID
- C-Cost2
- Conditions
- Colorectal Cancer, Advanced Adenoma
- Keywords
- FIT; FIT-sDNA; Colorectal cancer; Advanced colorectal adenoma; Early screening; Average risk population
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,504 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (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. Stool DNA tests detect DNA biomarkers of tumor cells in the stool and have higher sensitivity in detecting advanced colorectal neoplasms. USPSTF has recommended FIT-sDNA as initial screening tests in the average risk population. Colorectal Cancer Early Screening in China (Clear-C) trial has reported FIT-sDNA had higher sensitivity than FIT in detecting advanced colorectal neoplasms among high risk population, yet there is a lack of randomized controlled trials (RCTs) directly comparing the effectiveness of FIT and FIT-sDNA for colorectal cancer screening in the average risk population in China.
In China Colorectal Cancer Screening Trial 2 (C-Cost2), we propose to perform a multicenter, individual-level randomized, parallel group trial directly comparing FIT and FIT-sDNA in the average risk population in China. The main research hypothesis is that the screening protocol of FIT-sDNA group (Group B) has a superior detection rate of advanced colorectal neoplasms compared to the FIT group (Group A).
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 7504 eligible participants at baseline. The study adopts an individual-level randomized design. After signing the informed consent form, eligible participants will be randomly assigned to 2 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:
- FIT group (n = 3752): 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-sDNA group (n = 3752): A new screening protocol is adopted. In the first 4 years of the screening phase, all participants will receive annual FIT-sDNA tests. Participants with positive FIT-sDNA 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-sDNA tests, have negative FIT-sDNA tests, have positive FIT-sDNA 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
- 2
| Arm | Type | Receives |
|---|---|---|
| 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-sDNA group | Experimental | Diagnostic Test: FIT-sDNAA new screening protocol is adopted. In the first 4 years of the screening phase, all participants will receive annual FIT-sDNA tests. Participants with positive FIT-sDNA 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-sDNA tests, have negative FIT-sDNA tests, have positive FIT-sDNA 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 |
|---|---|---|
| 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-sDNAFIT-sDNA test combines Fecal Immunochemical Test (FIT) and stool DNA (sDNA) analysis. It detects hemoglobin in stool through FIT to identify occult blood in the gastrointestinal tract and simultaneously analyzes specific DNA mutations or epigenetic alterations (such as methylation changes) in stool DNA to assess the risk of colorectal neoplasms. | Diagnostic test | FIT-sDNA group |
Primary outcome
Detection rate of advanced colorectal neoplasms
Time frame: 4 years
Advanced colorectal neoplasms includes advanced adenomas and colorectal cancer
7 secondary outcomes
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
Mortality 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 29 Jul 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing FIT and FIT-sDNA in people with Colorectal Cancer and Advanced Adenoma, run by Zhejiang University.
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: opening soon, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 (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?
Detection rate of advanced colorectal neoplasms (time frame: 4 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 29 Jul 2025.