NCT04959617

Brief Summary

In order to control the incidence of colorectal cancer, improve the level of early diagnosis and early warning the occurrence of colorectal cancer, it is very necessary for us to explore the threshold value of FIT positive judgment in line with the Chinese population, and further contribute to the establishment of a colorectal cancer screening pathway suitable for Chinese healthy population

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
500,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 6, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 9, 2021

Status Verified

July 1, 2021

Enrollment Period

3 years

First QC Date

July 11, 2021

Last Update Submit

November 2, 2021

Conditions

Colorectal Cancer Screening Fecal Immunochemical Test

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of quantitative FIT

    The sensitivity of quantitative FIT application in Chinese physical examination population

    1year

  • Specificity of quantitative FIT

    The specificity of quantitative FIT application in Chinese physical examination population

    1year

Interventions

Quantitative Fecal Immunochemical Test (qFIT)DEVICE

The study only included quantitative FIT examination in the general physical examination population over 30 years old.

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy physical examination person over 30 years of age

You may qualify if:

  • Healthy people aged 30 years and planning to undergo colonoscopy;
  • No history of gastrointestinal tumor;
  • No ulcerative colitis or Crohn's disease;
  • No gastrointestinal hemorrhagic disease;
  • No history of gastrointestinal surgery, able to understand and willing to sign informed consent.

You may not qualify if:

  • Other serious diseases of the digestive tract, such as Crohn's disease ulcerative colitis;
  • Patients with gastric and esophageal cancer and other malignant tumors;
  • Unable to cooperate after communication;
  • Subjects who have received radiotherapy and chemotherapy;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

Study Design

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

Study Record Dates

First Submitted

July 11, 2021

First Posted

July 13, 2021

Study Start

January 6, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

November 9, 2021

Record last verified: 2021-07

Locations

CN(1)