Clinical trial NCT04823793: Fecal DNA Methylation Test for Colorectal Cancer Screening
Official title: A Fecal DNA Methylation Test for Colorectal Cancer Screening Using Multitarget Real-Time PCR Method-A Observational, Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Colorectal Adenoma
Keywords: Fecal immunochemical testing
Methylation
Stool
Colonoscopy
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy group :

Participants without any cancerous lesion in their colon

Disease group :

Participants with adenoma or colorectal cancer

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.

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.

Primary outcomes:
measure: Sensitivity and specificity of methylation biomarker and FIT for adenoma and colorectal cancer screening
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital, National Defense Medical Center
Study officials:
affiliation: Tri-Service General Hospital
name: Yi-Chiao Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References: