Evaluation of Different Colorectal Cancer Screening Strategies

NCT ID: NCT05440565

Last Updated: 2022-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-31

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Risk score

Group Type PLACEBO_COMPARATOR

APCS score

Intervention Type DIAGNOSTIC_TEST

APCS score can concentrate the high-risk population.

Fecal immunochemical test

Group Type ACTIVE_COMPARATOR

Fecal immunochemical test

Intervention Type DIAGNOSTIC_TEST

Fecal immunochemical test can concentrate the high-risk population.

Interventions

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Fecal immunochemical test

Fecal immunochemical test can concentrate the high-risk population.

Intervention Type DIAGNOSTIC_TEST

APCS score

APCS score can concentrate the high-risk population.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice President of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2022SDU-QILU-106

Identifier Type: -

Identifier Source: org_study_id

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