Evaluation of Colorectal Cancer Screening Strategies in China

S

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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