Establishment and Clinical Validation of New Technologies for Accurate Screening of Colorectal Cancer Based on Multi-omics

NCT ID: NCT04913233

Last Updated: 2021-06-04

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

Total Enrollment

9000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-31

Study Completion Date

2024-11-30

Brief Summary

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Background:

The current screening techniques for colorectal cancer include colonoscopy, fecal occult blood, and high-risk factor questionnaires. However, the colorectal cancer screening technology that has been widely used at present cannot take into account sensitivity and specificity, and the tumor detection rate is low.

The purpose of research:

1. Build a new type of population colorectal cancer precision screening technology program;
2. Improve the detection rate of colorectal cancer in the population by new methods (compared with the existing domestic advanced technology) by ≥20%, and improve the specificity of colorectal cancer screening by ≥15% without significantly reducing the sensitivity.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Age: 40-74 years old

Exclusion Criteria

1. Combine severe disorders to make it unsuitable for colonoscopy
2. Combine other tumors
3. Mental and behavioral abnormalities do not cooperate with the screener
4. Researchers believe that other reasons are not suitable for enrollment
Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chinese Medicine Hospital of Haining City, Haining Cancer Preventional and Treatment Research Institute

Haining, Zhejiang, China

Site Status

Jiashan County Cancer Prevention and Treatment Institute

Jiashan, Zhejiang, China

Site Status

Lanxi City People's Hospital, Linjiang Hospital

Lanxi, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Ying Yuan

Role: CONTACT

+8613858193601

Yanqin Huang

Role: CONTACT

+8613588418080

Facility Contacts

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Weihua Ma

Role: primary

Xinglin Fei

Role: primary

Weifang Zheng

Role: primary

Other Identifiers

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2021-0199

Identifier Type: -

Identifier Source: org_study_id

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