Fecal DNA Methylation Test for Colorectal Cancer Screening

NCT ID: NCT04823793

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2023-03-20

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.

Conditions

Colorectal Cancer; Colorectal Adenoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy group : Stool specimens from participants with healthy colon

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.

Stool DNA methylation detection

Intervention Type: DIAGNOSTIC_TEST

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.

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

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.

Stool DNA methylation detection

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yi-Chiao Cheng

Attending surgeon, division of colon and rectal surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yi-Chiao Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Tri-Service General Hospital

Locations

Tri-Service General Hospital, National Defense Medical Center

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yi-Chiao Cheng, MD

Role: CONTACT

ndmcjoe@gmail.com

+886912959022

Facility Contacts

Yi-Chiao Cheng

Role: primary

ndmcjoe@gmail.com

+886912959022

Other Identifiers

A202105054

Identifier Type: -

Identifier Source: org_study_id