Fecal DNA Methylation Test for Colorectal Cancer Screening

Tri-Service General Hospital

Status: Unknown

Conditions: Colorectal Adenoma; Colorectal Cancer

Treatments: Diagnostic Test: Stool DNA methylation detection

Study type: Observational

Funder types: Other

Identifiers

NCT04823793

A202105054

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 40 to 79 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

80 participants in 2 patient groups

Healthy group : Stool specimens from participants with healthy colon

Description:

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.

Treatment:

Diagnostic Test: Stool DNA methylation detection

Disease group : Stool specimens from participants with adenoma/colorectal cancer

Description:

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.

Treatment:

Diagnostic Test: Stool DNA methylation detection