Colorectal Neoplasms
Conditions
Brief summary
A large-scale randomized controlled trial was conducted to compare different colorectal neoplasms screening strategies in China.
Interventions
DIAGNOSTIC_TESTQualitative Fecal immunochemical test + APCS score
Risk stratification using Qualitative Fecal immunochemical test and APCS score
DIAGNOSTIC_TESTQuantitative Fecal immunochemical test
Use Quantitative Fecal immunochemical only for risk stratification
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* 50-74 years old * Informed consent is available
Exclusion criteria
* Previous colorectal cancer * Previous colorectal resection * Previous received cancer-related treatment (except non-melanoma skin cancer) * Colonoscopy, sigmoidoscopy, CT colonoscopy, and barium enema were performed within 5 years * Fecal occult blood or fecal DNA was performed within one year * Symptoms of lower digestive tract diseases requiring colonoscopy include: (1) rectal bleeding occurred more than once in the past 6 months, (2) recorded iron deficiency anemia, and (3) recorded significant weight loss within 6 months (\> 10% of baseline weight - Suffering from other diseases that affect the benefit of screening or intolerance to colonoscopy (for example, severe pulmonary disease, end-stage renal disease, end-stage liver disease, severe heart failure or recently diagnosed cancer, except non-melanoma skin cancer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate | up to 30 months | Detection of intestinal lesions |
Outcome results
None listed