Fecal DNA Methylation Test for Colorectal Cancer Screening

• Conditions: Colorectal Cancer; Colorectal Adenoma
• Interventions: Diagnostic Test: Stool DNA methylation detection

• Registration Number: NCT04823793
• Lead Sponsor: Tri-Service General Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-28
• Study Start: 2021-03-31
• Status Verified: 2021-04
• Study First Posted: 2021-04-01
• Last Update Submitted: 2021-04-03
• Last Update Posted: 2021-04-08
• Primary Completion: 2023-03-20
• Study Completion: 2023-03-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Disease group : Stool specimens from participants with adenoma/colorectal cancer	Stool DNA methylation detection	Stool specimens will be collected from participants before having a colonoscopy. If the participant's colon has precancerous lesion, such as adenoma, the stool specimen will be included in the disease group. Also, specimens from confirmed colorectal cancer patients are included in the disease group.
Healthy group : Stool specimens from participants with healthy colon	Stool DNA methylation detection	Stool specimens will be collected from participants before having a colonoscopy. If the participant's colon has a healthy colon without any cancerous lesion, the stool specimen will be included in the healthy group.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of methylation biomarker and FIT for adenoma and colorectal cancer screening	6 months	In this study, we estimate the sensitivity and specificity of methylation biomarker isolated from participant's stool DNA and perform FIT simultaneously.; The Ct values of candidate genes and GAPDH (reference gene) are determined by real-time PCR. The delta Ct values are calculated by Ct value of candidate gene - Ct value of GAPDH. Furthermore, the cut-off value of each candidate gene was determined based on the Receiver Operating Characteristic curve.; If the value of Fecal immunochemical test is more than 100 ng Hb/ml, the stool is considered as positive with fecal occult blood.

Trial Locations

Locations (1)

Tri-Service General Hospital, National Defense Medical Center; 🇨🇳 Taipei, Taiwan