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Using Two Different Cut-Off Levels of Fecal Immunochemical Test in the High-Risk and Non-High-Risk Subjects to Maintain the High-Rate Detection of Advanced Colorectal Neoplasia: A Population-Based Colorectal Cancer Screening in Thailand

Using Two Different Cut-Off Levels of Fecal Immunochemical Test in the High-Risk and Non-High-Risk Subjects to Maintain the High-Rate Detection of Advanced Colorectal Neoplasia: A Population-Based Colorectal Cancer Screening in Thailand

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20231102010
Enrollment
12000
Registered
2023-11-02
Start date
2019-03-06
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Introduction to the research problem and its significance. Evidences from Western and Asia Pacific countries shows that colorectal cancer (CRC) screening could reduce the incidence and mortality of CRC. According to many guidelines recommendation, the CRC screening should be started at the age of 50 in the general population. Currently, colonoscopy is the most effective screening tool. Because it has a high accuracy in a cancer and polyp detection and colonoscopy also provides the ability to pe

Interventions

FIT cutoff of 5 micrograms per gram to define FIT positivity for high-risk subjects and the cutoff of 20 micrograms per gram to define FIT positivity for non-high-risk subjects. (FIT5/20) , The other
Screening,Screening
FIT5/20,FIT20

Sponsors

The Royal College of Physicians of Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria 1. All participant with age 50-75 years 2. Participant with age 40-75 if participant has the first degree relative of CRC before age 50 3. Provide inform consent to participate in the study

Exclusion criteria

Exclusion criteria: Exclusion criteria 1. Symptoms that suspected gastrointestinal cancer such as hematochezia, bowel habit change, or weight loss 2. Had been diagnosed colorectal cancer or inflammatory bowel disease 3. There are severe comorbid diseases that limits life-expectancy such as end stage of cancer, heart disease or lung disease

Design outcomes

Primary

MeasureTime frame
positive predictive value (PPV) After fecal immunochemical test was analyzed by OC-SENSOR PLEDIA, total processing about 7 minites. OC-SENSOR PLEDIA, Eiken Chemical

Secondary

MeasureTime frame
the number needed to screen (NNS) to detect AN through FIT 2 weeks, After pathology reported. Colonoscopy

Countries

Thailand

Contacts

Public ContactAssist. Prof. Satimai Aniwan

Faculty of Medicine, Chulalongkorn University

satimai@gmail.com66256400

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026