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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
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Neoplasms

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept 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)

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

    First Posted
    June 23, 2022
    Last Updated
    June 29, 2022
    Sponsor
    Shandong University
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    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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