Colorectal CancerSMART-CRCNCT07180303
Colorectal Cancer Screening in Chinese Rural Communities
A study testing Continuation of routine healthcare services without any additional training interventions. in people with Colorectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Colorectal cancer (CRC) is one of the most common malignant neoplasms significantly impacting population health and longevity. With the transformation of lifestyle and dietary patterns among Chinese residents, coupled with an increasingly aging population, both the incidence and mortality rates of CRC in China have… Read more about this study
- Who is it for?
- Ages 45 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Continuation of routine healthcare services without any additional training interventions.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20,026 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 30 Apr 2026
- Phase
- Interventional
- 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 45 and 74 years old (inclusive).
- Permanent resident within the geographic area covered by the screening program (typically defined as residing in the area for a minimum period, e.g., 6 months or more), and possessing local household registration (hukou) or residency documentation.
- Self-reported absence of symptoms suggestive of colorectal cancer (e.g., rectal bleeding, change in bowel habits, abdominal pain, palpable abdominal mass, unexplained anemia, or unintentional weight loss).
- No prior diagnosis of colorectal cancer or precancerous lesions (e.g., high-grade intraepithelial neoplasia, serrated lesions with dysplasia).
- Not currently participating in another colorectal cancer-related clinical study that might interfere with the screening outcomes.
- Willing and able to provide written informed consent, agreeing to participate in the screening program and comply with subsequent follow-up procedures (e.g., fecal testing, colonoscopy).
Who cannot join
- Previous diagnosis of colorectal cancer, history of resection of colorectal polyps (especially high-grade lesions or serrated lesions with dysplasia), or diagnosis of inflammatory bowel disease (ulcerative colitis, Crohn's disease).
- Completion of a high-quality colonoscopy within a specified timeframe (e.g., within the past 1 year) with normal results (no polyps or only 1-2 tubular adenomas <10mm), or completion of a high-quality sigmoidoscopy within a specified timeframe (e.g., within the past 3 years) with normal results.
- Presence of severe comorbid conditions (e.g., severe cardiac, pulmonary, hepatic, or renal insufficiency) resulting in a life expectancy of less than 10 years, or physical condition unable to tolerate colonoscopy and bowel preparation.
- Conditions such as severe coagulopathy, recent acute myocardial infarction or stroke (e.g., within the past 3 months), or severe psychiatric illness preventing cooperation.
- Generally excluded due to safety considerations regarding screening colonoscopy during these periods.
- Inability to understand the study content and provide informed consent due to cognitive impairment, language barriers, or other reasons.
- Judged by the investigator to have a very high likelihood of being lost to follow-up during the study period, making completion of the screening pathway unlikely.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Community-Based Cluster Randomized Trial Evaluating a Colorectal Cancer Screening Program Integrated Within the Rural Primary Healthcare System in China
Colorectal cancer (CRC) is one of the most common malignant neoplasms significantly impacting population health and longevity. With the transformation of lifestyle and dietary patterns among Chinese residents, coupled with an increasingly aging population, both the incidence and mortality rates of CRC in China have exhibited a sustained upward trend. CRC often presents with insidious onset; the five-year survival rate for patients diagnosed at intermediate or advanced stages remains below 15%. In contrast, early diagnosis and treatment can achieve a five-year survival rate exceeding 90%. Furthermore, population-based CRC screening in mainland China is still in its nascent stages. Although preliminary, small-to-medium-scale screening programs have been implemented in certain regions, participation rates in risk assessment questionnaires and fecal occult blood testing remain suboptimal, attributable to regional disparities and variations in cultural and educational backgrounds. Moreover, adherence to the pivotal diagnostic procedure-colonoscopy-within screening programs is notably low, estimated at approximately 20% to 30%. Consequently, more refined and scientifically grounded mobilization and educational campaigns are critically important to enhance participation in population-based CRC screening initiatives.
Read the detailed description
- Background and Objectives This study aims to investigate, through a cluster randomized controlled trial (RCT), whether remote training for primary care physicians can effectively enhance the accessibility and adherence to colorectal cancer (CRC) screening. Specifically, the intervention group will receive professional training on CRC screening guidelines, standards of care for high-risk individuals, and dietary interventions, while the control group will receive no additional training. The ultimate goal is to improve community residents' awareness of colorectal cancer, increase screening participation, and reduce both incidence and mortality rates.
- Study Design
- Target Population: Fifteen natural villages within a county or city will be selected as study sites, encompassing permanent residents aged between 45 and 74 years.
- Randomization: A cluster randomization method will be employed to randomly assign the 15 villages to either Group A (intervention group) or Group B (control group). Each group will include at least seven villages to ensure adequate sample size.
- Sample Size Calculation: The required sample size will be determined based on estimated changes in screening adherence rates and other relevant parameters.
- Intervention
- Intervention Group (Group A):
- Remote training courses covering the latest CRC screening guidelines, identification of high-risk individuals and their standard of care, and dietary intervention strategies.
- Ongoing support services, such as regular knowledge updates and technical consultations.
- Control Group (Group B):
- Continuation of routine healthcare services without any additional training interventions.
- Data Collection and Analysis
- Primary Outcome Measures:
- Phase I: Improvement in colonoscopy adherence.
- Phase II: Trends in colorectal cancer incidence.
- Phase III: Long-term impact on colorectal cancer mortality.
- Secondary Outcome Measures: Participants' understanding of CRC prevention and control, changes in lifestyle behaviors, etc.
- Data Analysis: Appropriate statistical software will be used to analyze the data, comparing differences between the two groups while accounting for potential confounding factors.
- Potential Supplementary Aspects
- Community Education: Strengthen health education activities at the community level to enhance public awareness of colorectal cancer and self-protection.
- Cost-Effectiveness Analysis: Conduct a cost-effectiveness analysis to evaluate the economic benefits of the intervention.
- Ethical Considerations: Ensure all participants are fully informed about the study's purpose and provide consent, while safeguarding individual privacy.
- Feasibility Assessment
- Resource Availability: Confirm sufficient funding to support project operations, including development of training materials and maintenance of the technological platform.
- Technical Readiness: Ensure the technical requirements for remote training are met, such as stable internet connectivity and a user-friendly learning management system.
- Personnel Training: Ensure participating healthcare providers possess the necessary foundational knowledge and can effectively apply the acquired knowledge in clinical practice.
- Conditions
- Colorectal Cancer
- Being tested
- Remote training courses covering the latest CRC screening guidelines, identification of high-risk individuals and their standard of care, and dietary intervention strategies. Ongoing support services,, Continuation of routine healthcare services without any additional training interventions.
- Keywords
- Screen, Integrated CRC Screening Program
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote training courses covering the latest CRC screening guidelines, identification of high-risk individuals and their standard of care, and dietary intervention strategies. Ongoing support services,Other
Remote training courses covering the latest CRC screening guidelines, identification of high-risk individuals and their standard of care, and dietary intervention strategies.
Ongoing support services, such as regular knowledge updates and technical consultations.
Continuation of routine healthcare services without any additional training interventions.Other
Continuation of routine healthcare services without any additional training interventions.
| Study group | Role | What they receive |
|---|---|---|
| Integrated CRC Screening Program | Experimental | * Provide remote training courses covering the latest colorectal cancer screening guidelines, methods for identifying high-risk individuals and their standards of care, as well as dietary intervention strategies.
* Offer ongoing support services, such as regular knowledge updates and technical consultations. Receives: Other: Remote training courses covering the latest CRC screening guidelines, identification of high-risk individuals and their standard of care, and dietary intervention strategies. Ongoing support services, |
| Standard Care / Usual Practice | Sham comparator | Current opportunistic screening practices within the rural primary healthcare system. Receives: Other: Continuation of routine healthcare services without any additional training interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in colonoscopy adherence
Proportion of patients undergoing colonoscopy, The proportion of patients who, after questionnaire screening and fecal occult blood testing, are indicated for colonoscopy and ultimately undergo the procedure.
Measured: 1 year
Secondary outcomes (1)
Trends in colorectal cancer incidence
Trends in colorectal cancer incidence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Aug 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
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 The First Affiliated Hospital with Nanjing Medical 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
- 20,026 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180303
- Sponsor's protocol ID
- Rural CRC Screen
- Acronym
- SMART-CRC
- Status last verified
- Aug 2025
- First submitted
- 31 Aug 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will provide de-identified information of all individuals included in the screening in a public database, which will be accessible through an online platform. Access will be granted upon submission of a reasonable request to the lead investigator of this study.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-Based Cluster Randomized Trial Evaluating a Colorectal Cancer Screening Program Integrated Within the Rural Primary Healthcare System in China
- ClinicalTrials.gov ID
- NCT07180303
- Acronym / sponsor ID
- SMART-CRC / Rural CRC Screen
- Conditions
- Colorectal Cancer
- Keywords
- Screen, Integrated CRC Screening Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,026 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Nanjing Medical University
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 18 Sep 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 malignant neoplasms significantly impacting population health and longevity. With the transformation of lifestyle and dietary patterns among Chinese residents, coupled with an increasingly aging population, both the incidence and mortality rates of CRC in China have exhibited a sustained upward trend. CRC often presents with insidious onset; the five-year survival rate for patients diagnosed at intermediate or advanced stages remains below 15%. In contrast, early diagnosis and treatment can achieve a five-year survival rate exceeding 90%. Furthermore, population-based CRC screening in mainland China is still in its nascent stages. Although preliminary, small-to-medium-scale screening programs have been implemented in certain regions, participation rates in risk assessment questionnaires and fecal occult blood testing remain suboptimal, attributable to regional disparities and variations in cultural and educational backgrounds. Moreover, adherence to the pivotal diagnostic procedure-colonoscopy-within screening programs is notably low, estimated at approximately 20% to 30%. Consequently, more refined and scientifically grounded mobilization and educational campaigns are critically important to enhance participation in population-based CRC screening initiatives.
Detailed description
- Background and Objectives This study aims to investigate, through a cluster randomized controlled trial (RCT), whether remote training for primary care physicians can effectively enhance the accessibility and adherence to colorectal cancer (CRC) screening. Specifically, the intervention group will receive professional training on CRC screening guidelines, standards of care for high-risk individuals, and dietary interventions, while the control group will receive no additional training. The ultimate goal is to improve community residents' awareness of colorectal cancer, increase screening participation, and reduce both incidence and mortality rates.
- Study Design
- Target Population: Fifteen natural villages within a county or city will be selected as study sites, encompassing permanent residents aged between 45 and 74 years.
- Randomization: A cluster randomization method will be employed to randomly assign the 15 villages to either Group A (intervention group) or Group B (control group). Each group will include at least seven villages to ensure adequate sample size.
- Sample Size Calculation: The required sample size will be determined based on estimated changes in screening adherence rates and other relevant parameters.
- Intervention
- Intervention Group (Group A):
- Remote training courses covering the latest CRC screening guidelines, identification of high-risk individuals and their standard of care, and dietary intervention strategies.
- Ongoing support services, such as regular knowledge updates and technical consultations.
- Control Group (Group B):
- Continuation of routine healthcare services without any additional training interventions.
- Data Collection and Analysis
- Primary Outcome Measures:
- Phase I: Improvement in colonoscopy adherence.
- Phase II: Trends in colorectal cancer incidence.
- Phase III: Long-term impact on colorectal cancer mortality.
- Secondary Outcome Measures: Participants' understanding of CRC prevention and control, changes in lifestyle behaviors, etc.
- Data Analysis: Appropriate statistical software will be used to analyze the data, comparing differences between the two groups while accounting for potential confounding factors.
- Potential Supplementary Aspects
- Community Education: Strengthen health education activities at the community level to enhance public awareness of colorectal cancer and self-protection.
- Cost-Effectiveness Analysis: Conduct a cost-effectiveness analysis to evaluate the economic benefits of the intervention.
- Ethical Considerations: Ensure all participants are fully informed about the study's purpose and provide consent, while safeguarding individual privacy.
- Feasibility Assessment
- Resource Availability: Confirm sufficient funding to support project operations, including development of training materials and maintenance of the technological platform.
- Technical Readiness: Ensure the technical requirements for remote training are met, such as stable internet connectivity and a user-friendly learning management system.
- Personnel Training: Ensure participating healthcare providers possess the necessary foundational knowledge and can effectively apply the acquired knowledge in clinical practice.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated CRC Screening Program | Experimental | Other: Remote training courses covering the latest CRC screening guidelines, identification of high-risk individuals and their standard of care, and dietary intervention strategies. Ongoing support services,* Provide remote training courses covering the latest colorectal cancer screening guidelines, methods for identifying high-risk individuals and their standards of care, as well as dietary intervention strategies. * Offer ongoing support services, such as regular knowledge updates and technical consultations. |
| Standard Care / Usual Practice | Sham comparator | Other: Continuation of routine healthcare services without any additional training interventions.Current opportunistic screening practices within the rural primary healthcare system. |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between 45 and 74 years old (inclusive).
- Permanent resident within the geographic area covered by the screening program (typically defined as residing in the area for a minimum period, e.g., 6 months or more), and possessing local household registration (hukou) or residency documentation.
- Self-reported absence of symptoms suggestive of colorectal cancer (e.g., rectal bleeding, change in bowel habits, abdominal pain, palpable abdominal mass, unexplained anemia, or unintentional weight loss).
- No prior diagnosis of colorectal cancer or precancerous lesions (e.g., high-grade intraepithelial neoplasia, serrated lesions with dysplasia).
- Not currently participating in another colorectal cancer-related clinical study that might interfere with the screening outcomes.
Key exclusion criteria (7 listed)
- Previous diagnosis of colorectal cancer, history of resection of colorectal polyps (especially high-grade lesions or serrated lesions with dysplasia), or diagnosis of inflammatory bowel disease (ulcerative colitis, Crohn's disease).
- Completion of a high-quality colonoscopy within a specified timeframe (e.g., within the past 1 year) with normal results (no polyps or only 1-2 tubular adenomas <10mm), or completion of a high-quality sigmoidoscopy within a specified timeframe (e.g., within the past 3 years) with normal results.
- Presence of severe comorbid conditions (e.g., severe cardiac, pulmonary, hepatic, or renal insufficiency) resulting in a life expectancy of less than 10 years, or physical condition unable to tolerate colonoscopy and bowel preparation.
- Conditions such as severe coagulopathy, recent acute myocardial infarction or stroke (e.g., within the past 3 months), or severe psychiatric illness preventing cooperation.
- Generally excluded due to safety considerations regarding screening colonoscopy during these periods.
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 |
|---|---|---|
| Remote training courses covering the latest CRC screening guidelines, identification of high-risk individuals and their standard of care, and dietary intervention strategies. Ongoing support services,Remote training courses covering the latest CRC screening guidelines, identification of high-risk individuals and their standard of care, and dietary intervention strategies. Ongoing support services, such as regular knowledge updates and technical consultations. | Other | Integrated CRC Screening Program |
| Continuation of routine healthcare services without any additional training interventions.Continuation of routine healthcare services without any additional training interventions. | Other | Standard Care / Usual Practice |
Primary outcome
Improvement in colonoscopy adherence
Time frame: 1 year
Proportion of patients undergoing colonoscopy, The proportion of patients who, after questionnaire screening and fecal occult blood testing, are indicated for colonoscopy and ultimately undergo the procedure.
1 secondary outcome
Trends in colorectal cancer incidence
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes. We will provide de-identified information of all individuals included in the screening in a public database, which will be accessible through an online platform. Access will be granted upon submission of a reasonable request to the lead investigator of this study.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuation of routine healthcare services without any additional training interventions. in people with Colorectal Cancer, run by The First Affiliated Hospital with Nanjing Medical 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 6 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: finished, as of the sponsor's last update on 21 Jul 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in colonoscopy adherence (time frame: 1 year). 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 21 Jul 2026.