NCT04913233

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. 1.Build a new type of population colorectal cancer precision screening technology program;
  2. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

June 4, 2021

Status Verified

May 1, 2021

Enrollment Period

2.9 years

First QC Date

May 30, 2021

Last Update Submit

May 30, 2021

Conditions

Keywords

Colorectal cancerCancer ScreeningColonoscopyAPCSHRFQ

Outcome Measures

Primary Outcomes (3)

  • Colorectal cancer detection rate in the population

    Colorectal cancer detection rate in the population

    through study completion, an average of 3 years

  • Colorectal cancer screening specificity

    Colorectal cancer screening specificity

    through study completion, an average of 3 years

  • Colorectal cancer screening sensitivity

    Colorectal cancer screening sensitivity

    through study completion, an average of 3 years

Eligibility Criteria

Age40 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals of 40-74 years old in non-high incidence of colorectal cancer areas(hospital outpatient population, community population in non-high-risk areas) .

You may qualify if:

  • Age: 40-74 years old

You may not qualify if:

  • Combine severe disorders to make it unsuitable for colonoscopy
  • Combine other tumors
  • Mental and behavioral abnormalities do not cooperate with the screener
  • Researchers believe that other reasons are not suitable for enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Haining, Zhejiang, 314400, China

Location

Jiashan County Cancer Prevention and Treatment Institute

Jiashan, Zhejiang, 314100, China

Location

Lanxi City People's Hospital, Linjiang Hospital

Lanxi, Zhejiang, 321100, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2021

First Posted

June 4, 2021

Study Start

July 1, 2021

Primary Completion

June 1, 2024

Study Completion

November 1, 2024

Last Updated

June 4, 2021

Record last verified: 2021-05

Locations