NCT05200611

Brief Summary

Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. In order to reduce the incidence of colorectal cancer, improve the early diagnosis of colorectal cancer, the investigators conducted this study to explore diagnostic accuracy of fecal immunochemical test in colorectal cancer screening 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
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 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

January 3, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

January 4, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

January 3, 2022

Last Update Submit

January 16, 2022

Conditions

Keywords

Colorectal AdenomaOccult BleedingQuantitative fecal immunochemical test

Outcome Measures

Primary Outcomes (1)

  • The efficacy of fecal immunochemical test to detect advanced adenoma

    The detection rate and positive predictive value of fecal immunochemical test to detect advanced adenoma

    6 months

Secondary Outcomes (2)

  • The efficacy of fecal immunochemical test to detect colorectal cancer

    6 month

  • The efficacy of fecal immunochemical test to detect colorectal neoplasms

    6 month

Study Arms (1)

Fecal Immunochemical Test

People in this group with positive fecal immunochemical test results were further examined by colonoscopy.

Diagnostic Test: Fecal Immunochemical Test

Interventions

Participants with positive fecal immunochemical test results were further examined by colonoscopy.

Fecal Immunochemical Test

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Continuous participants intending to undergo colonoscopy and meet the inclusion and exclusion criteria were enrolled.

You may qualify if:

  • Adults 50-75 years old

You may not qualify if:

  • People with history of intestinal surgery;
  • People with history of colorectal cancer;
  • People with history of inflammatory bowel disease, ischemic enteritis, vascular malformation of intestine or other disease resulting in intestinal tract bleeding;
  • People with symptoms including visible rectal bleeding, hematuria, severe and acute diarrhea;
  • Pregnancy, lactation or menstrual phase;
  • Severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shanghe People's Hospital

Jinan, Shandong, 250012, China

NOT YET RECRUITING

The People's Hospital of Zhaoyuan City

Yantai, Shandong, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

faeces

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
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 3, 2022

First Posted

January 21, 2022

Study Start

January 4, 2022

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

January 21, 2022

Record last verified: 2022-01

Locations