Colorectal Tumor
Conditions
Keywords
colorectal cancer, advanced adenoma, circulating tumor DNA methylation
Brief summary
This is a prospective diagnostic study. This study is to compare the performance between circulating tumor DNA (ctDNA) methylation and carcinoembryonic antigen (CEA) in detecting colorectal tumor. Firstly, based on the identification of differential ctDNA methylation biomarkers, the diagnostic model is established and the diagnostic performance was compared with that of CEA. Secondly, the stage stratification model was established preliminarily based on differential ctDNA methylation biomarkers and the performance was also compared with that of CEA.
Detailed description
Colorectal cancer (CRC) is the third most common cancer worldwide, the second deadliest cancer. It is reported that patients prefer non-invasive methods rather than invasive methods for the detection of CRC. Carcinoembryonic antigen (CEA) is commonly employed in clinical practice for early detection of CRC, but it is limited for its low sensitivity, which is around 30%-40%. DNA methylation is a commonly used biomarker for non-invasive tumor detection in plasma. We aim to develop and validate a ctDNA methylation-based blood test for CRC diagnosis based on genome-wide methylation detection. There are two steps in the study. Firstly, this prospective study aims to identify colorectal tumor differential circulating tumor DNA (ctDNA) methylation biomarkers, establish the diagnostic model. Secondly, we performed a preliminary study to stratify early-stage and advanced-stage disease based on the differential biomarkers.
Interventions
DIAGNOSTIC_TESTGenome-wide methylation profiling
Detection for colorectal tumor-specific ctDNA methylation biomarkers
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Case group * Patients must have histologically confirmed colorectal cancer or advanced adenoma. * Patients need to receive surgical resection or endoscopic resection. * Patients have a performance status of ≤1 on the ECOG Performance Scale. * Written informed consent must be obtained. Control group * Written informed consent must be obtained. * Individuals must receive colonoscopy.
Exclusion criteria
* Patients received tumor treatment prior to the drawn of blood sample, including surgical resection, neoadjuvant chemoradiotherapy and targeted therapy. * Patients received antibiotics regularly. * Patients received blood transfusion two weeks before the drawn of blood sample. * Patients with indications of emergency surgery, including bleeding, obstruction and perforation. * Patients who are positive for Human Immunodeficiency Virus (HIV). * Patients with abnormal liver and kidney function. * Patients with the history of other malignancies, inflammatory bowel disease and Lynch syndrome. * Patients who are pregnant or breastfeeding. * Alcoholic or drug abusers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic sensitivity | 3 years | The comparison of sensitivity between ctDNA methylation and CEA in detecting colorectal cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stage stratification | 3 years | The performance of the novel model to stratify early-stage and advanced-stage disease, and comparing with that of CEA. |
Countries
China
Outcome results
None listed