Evaluation of Colorectal Cancer Screening Strategies in China

Shandong University

Status: Not yet enrolling

Conditions: Colorectal Neoplasms

Treatments: Diagnostic Test: Quantitative Fecal immunochemical test; Diagnostic Test: Qualitative Fecal immunochemical test + APCS score

Study type: Interventional

Funder types: Other

Identifiers

NCT05440552

2022SDU-QILU-107

Details and patient eligibility

About

A large-scale randomized controlled trial was conducted to compare different colorectal neoplasms screening strategies in China.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 50 to 74 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20,000 participants in 2 patient groups, including a placebo group

Risk score1

Placebo Comparator group

Treatment:

Diagnostic Test: Qualitative Fecal immunochemical test + APCS score

Risk score2

Active Comparator group

Treatment:

Diagnostic Test: Quantitative Fecal immunochemical test