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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04913233
• Other study ID #: 2021-0199
• Status: Not yet recruiting
• Start date: July 2021
• Est. completion date: November 2024

Study information

• Verified date: May 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Ying Yuan
• Phone: +8613858193601
• Email: yuanying1999[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9000
• Est. completion date: November 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
China	Chinese Medicine Hospital of Haining City, Haining Cancer Preventional and Treatment Research Institute	Haining	Zhejiang
China	Jiashan County Cancer Prevention and Treatment Institute	Jiashan	Zhejiang
China	Lanxi City People's Hospital, Linjiang Hospital	Lanxi	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colorectal cancer detection rate in the population	Colorectal cancer detection rate in the population	through study completion, an average of 3 years
Primary	Colorectal cancer screening specificity	Colorectal cancer screening specificity	through study completion, an average of 3 years
Primary	Colorectal cancer screening sensitivity	Colorectal cancer screening sensitivity	through study completion, an average of 3 years