Fecal Immunochemical Test for Advanced Adenoma Detection in Colorectal Cancer Screening
Application of Fecal Immunochemical Test for Improving Advanced Adenoma Detection in Colorectal Cancer Screening
1 other identifier
observational
5,000
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2022
CompletedStudy Start
First participant enrolled
January 4, 2022
CompletedFirst Posted
Study publicly available on registry
January 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedJanuary 21, 2022
January 1, 2022
5 months
January 3, 2022
January 16, 2022
Conditions
Keywords
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.
Interventions
Participants with positive fecal immunochemical test results were further examined by colonoscopy.
Eligibility Criteria
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
- Shandong Universitylead
- The People's Hospital of Zhaoyuan Citycollaborator
- Shanghe People's Hospitalcollaborator
Study Sites (2)
Shanghe People's Hospital
Jinan, Shandong, 250012, China
The People's Hospital of Zhaoyuan City
Yantai, Shandong, China
Biospecimen
faeces
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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