Colorectal Cancer Screening in Xinxiang City

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT06785714
• Lead Sponsor: The First Affiliated Hospital of Xinxiang Medical College

Brief Summary

The primary objective of this study is to evaluate the sensitivity of the fecal protein dual-index test reagent for the detection of colorectal cancer (CRC).

Detailed Description

The project uses fecal hemoglobin and transferrin dual-index combined with reagents that can be self-tested at home (referred to as fecal protein dual-index detection reagents), combined with colorectal cancer risk factor questionnaires, to carry out colorectal cancer screening in people of specific ages in the city, aiming to achieve early screening, early diagnosis and early treatment, and evaluate the effect of fecal protein dual-index detection reagents in early screening of colorectal cancer, so as to provide a scientific basis for optimizing the national screening program.

Study Timeline

• Study Start: 2024-09-01
• Status Verified: 2025-01
• Primary Completion: 2025-01-15
• Study Completion: 2025-01-15
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-15
• Last Update Submitted: 2025-01-15
• Study First Posted: 2025-01-21
• Last Update Posted: 2025-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25000

Inclusion Criteria

1. Subjects aged 45-74 years at time of consent
2. Have not had gastrointestinal resection

Exclusion Criteria

1. Previous history of colorectal cancer
2. Patients who have been confirmed to have other malignant neoplastic diseases of the digestive system
3. Patients with severe heart, brain, lung disease or liver and kidney dysfunction or insufficiency
4. Those with severe mental disorders and language communication disorders
5. History of contraindications to colonoscopy
6. Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of colorectal cancer detection	180 days	Sensitivity of colorectal cancer detection
Specificity of advanced neoplasia detection	180 days	Specificity of advanced neoplasia detection

Secondary Outcome Measures

Name	Time	Method
Positive predictive value of colorectal cancer detection	180 days	Positive predictive value of colorectal cancer detection
Negative predictive value of colorectal cancer detection	180 days	Negative predictive value of colorectal cancer detection
Sensitivity and specificity of advanced adenoma detection	180 days	Sensitivity and specificity of advanced adenoma detection

Trial Locations

Locations (1)

The First Affiliated Hospital of Xinxiang Medical University; 🇨🇳 Xinxiang, Henan, China