Fecal DNA Methylation Test for Colorectal Cancer Screening

  • End date
    Mar 20, 2023
  • participants needed
  • sponsor
    Tri-Service General Hospital
Updated on 15 April 2021


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.


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.

Condition Colorectal Cancer, Colorectal Cancer, Colon Cancer Screening, Colon cancer; rectal cancer, Rectal disorder, Rectal Disorders, Colon Cancer Screening, Rectal Disorders, Colon cancer; rectal cancer, Colorectal Adenomas, Colorectal Adenoma, colorectal neoplasm, colorectal cancers, cancer, colorectal, colorectal tumor, tumors, colorectal
Treatment Stool DNA methylation detection
Clinical Study IdentifierNCT04823793
SponsorTri-Service General Hospital
Last Modified on15 April 2021


Yes No Not Sure

Inclusion Criteria

Participants with age over 40 but under 80, who need to take colonoscopy or diagnostic confirmed colorectal cancer patient

Exclusion Criteria

Participants who are undergoing cancer treatments or have diagnosed with cancer, received cancer treatment in the past
Participants who have received any cancer treatments, including chemotherapy and radiotherapy before taking surgery
Participants have received any surgery for colorectal cancer in the past
Pregnant women or nursing women
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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