Evaluation of Different Colorectal Cancer Screening Strategies
Primary Purpose
Colorectal Neoplasms
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fecal immunochemical test
APCS score
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Neoplasms
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Risk score
Fecal immunochemical test
Arm Description
Outcomes
Primary Outcome Measures
Detection rate
Detection of intestinal lesions in population
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05440565
Brief Title
Evaluation of Different Colorectal Cancer Screening Strategies
Official Title
Evaluation of Different Colorectal Cancer Screening Strategies: a Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A large-scale randomized controlled trial was conducted to compare different colorectal neoplasms screening strategies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Risk score
Arm Type
Placebo Comparator
Arm Title
Fecal immunochemical test
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Fecal immunochemical test
Intervention Description
Fecal immunochemical test can concentrate the high-risk population.
Intervention Type
Diagnostic Test
Intervention Name(s)
APCS score
Intervention Description
APCS score can concentrate the high-risk population.
Primary Outcome Measure Information:
Title
Detection rate
Description
Detection of intestinal lesions in population
Time Frame
up to 30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Different Colorectal Cancer Screening Strategies
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