Colorectal Cancer Screening in Chinese Rural Communities

NCT07180303 | Completed DMC

• 1 other identifier: RuralCRC Screen
• Study Type: interventional
• Target: 20,026
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Colorectal Cancer

Keywords

Screen; Integrated CRC Screening Program

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (2)

• Trends in colorectal cancer incidence

  1 year

• Long-term impact on colorectal cancer mortality

  5 year

Study Arms (2)

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.

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.

Other: Continuation of routine healthcare services without any additional training interventions.

Interventions

Continuation of routine healthcare services without any additional training interventions. OTHER

Continuation of routine healthcare services without any additional training interventions.

Standard Care / Usual Practice

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.

Integrated CRC Screening Program

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 45 and 70 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Medical University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Liyang Municipal Health Commission

Liyang, Jiangsu, 213300, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: September 18, 2025
• Study Start: June 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 3, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2 years
• Access Criteria: Access will be granted upon submission of a reasonable request to the lead investigator of this study.

Locations

CN (1)