Fecal DNA Methylation Test for Colorectal Cancer Screening

NCT04823793 | Unknown

• 1 other identifier: A202105054
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Colorectal Adenoma

Keywords

Fecal immunochemical testing; Methylation; Stool; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Diagnostic Test: Stool DNA methylation detection

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.

Diagnostic Test: Stool DNA methylation detection

Interventions

Stool DNA methylation detection 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; Healthy group : Stool specimens from participants with healthy colon

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Participants with age over 40 but under 80, who need to take colonoscopy or diagnostic confirmed colorectal cancer patient.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital, National Defense Medical Center

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

At least 40 specimens from participants with healthy colon at least 40 specimens from participants with adenoma/colorectal cancer

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yi-Chiao Cheng, MD

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Chiao Cheng, MD

CONTACT

+886912959022; ndmcjoe@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending surgeon, division of colon and rectal surgery

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: April 1, 2021
• Study Start: March 31, 2021
• Primary Completion: March 20, 2023
• Study Completion: March 20, 2023
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

TW (1)