Fecal DNA Methylation Test for Colorectal Cancer Screening

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04823793
• Other study ID #: A202105054
• Status: Recruiting
• Start date: March 31, 2021
• Est. completion date: March 20, 2023

Study information

• Verified date: April 2021
• Source: Tri-Service General Hospital
• Contact: Yi-Chiao Cheng, MD
• Phone: +886912959022
• Email: ndmcjoe[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital, National Defense Medical Center	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of methylation biomarker and FIT for adenoma and colorectal cancer screening	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.	6 months