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

Research on New Technologies for Screening and Early Diagnosis of Malignant Tumors - Establishment and Clinical Validation of New Technologies for Accurate Screening of Colorectal Cancer Based on Multi-omics

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04913233
Enrollment
9000
Registered
2021-06-04
Start date
2021-07-31
Completion date
2024-11-30
Last updated
2021-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Colorectal cancer, Cancer Screening, Colonoscopy, APCS, HRFQ

Brief summary

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.

Interventions

None listed

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Colorectal cancer detection rate in the populationthrough study completion, an average of 3 yearsColorectal cancer detection rate in the population
Colorectal cancer screening specificitythrough study completion, an average of 3 yearsColorectal cancer screening specificity
Colorectal cancer screening sensitivitythrough study completion, an average of 3 yearsColorectal cancer screening sensitivity

Countries

China

Contacts

Primary ContactYing Yuan
yuanying1999@zju.edu.cn+8613858193601
Backup ContactYanqin Huang
13588418080@163.com+8613588418080

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026