NCT04823793

Fecal DNA Methylation Test for Colorectal Cancer Screening

A Fecal DNA Methylation Test for Colorectal Cancer Screening Using Multitarget Real-Time PCR Method-A Observational, Prospective Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Tri-Service General Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 79 Years
• Healthy volunteers: Accepted

Summary

This is an observational, prospective study using fecal DNA methylation test to define the risk of suffering from advanced adenoma or colorectal cancer (CRC) compared to colonoscopy and fecal immunochemical test (FIT). This study recruits at least 80 participants, including 40 people of healthy controls, 20 people with adenoma, and 20 people with CRC, which were confirmed by colonoscopy. All fecal specimens from participants will be examined by FIT and multi-methylated target gene detection through real-time quantitative methylation-specific PCR (qMSP). The objective of this study is to evaluate the sensitivity and specificity of multi-methylated target PCR compared with the FIT and confirm the examination results through colonoscopy.

Detailed description

The incidence rate and the mortality rate of colorectal cancer (CRC) have been steadily increasing worldwide. Early detection of CRC can provide great opportunities to help patients, increasing their 5-year survival rate. Colonoscopy has been considered as the golden standard of CRC screening method, but the invasive procedures cannot be widely adapted by recipients. Nowadays, the most common CRC screening method is fecal immunochemical test (FIT) which is a cost-effective and non-invasive approach. The sensitivity of FIT for CRC detection is about 80%, but only 20% for adenoma. The methylation level of candidate genes are determined by qMSP to estimate the risk of colorectal cancer. This study implements fecal DNA methylation test and fecal immunochemical test simultaneously to evaluate whether the fecal DNA methylation test can improve the detection rate of adenoma and CRC.

Conditions

• Colorectal Cancer
• Colorectal Adenoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Stool DNA methylation detection	Stool specimens are collected from participants in the outpatient department or the inpatient department. Both FIT and stool DNA real-time PCR are performed simultaneously. To improve the sensitivity and specificity of the colorectal cancer screening, this study enrolls multiple candidate genes to distinguish whether the participant has a high risk of colorectal cancer.

Timeline

• Start date: 2021-03-31
• Primary completion: 2023-03-20
• Completion: 2023-03-20
• First posted: 2021-04-01
• Last updated: 2021-04-08

Locations

1 site across 1 country: Taiwan