Comparison of Diagnostic Sensitivity Between ctDNA Methylation and CEA in Colorectal Cancer

Study Overview
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Brief Summary
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This is a comparative study. This study is to compare the diagnostic sensitivity between circulating tumor DNA methylation and carcinoembryonic antigen in detecting colorectal cancer. There are two steps in this study. Firstly, the diagnostic model is established based on tumor-specific plasma circulating tumor DNA methylation markers. Secondly, the sensitivity, specificity and accuracy of plasma circulating tumor DNA methylation are compared with that of carcinoembryonic antigen in detecting colorectal cancer.

Detailed Description
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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 methylation-based blood test for CRC based on genome-wide methylation detection. There are two steps. Firstly, this prospective, clinical study aims to establish the diagnostic model based on tumor-specific plasma ctDNA methylation markers. Secondly, this study is to compare the sensitivity, specificity, accuracy, positive predictive value and negative predictive value of plasma circulating tumor DNA (ctDNA) methylation with CEA in detecting colorectal cancer.

Official Title
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Comparison of Diagnostic Sensitivity Between Circulating Tumor DNA Methylation and Carcinoembryonic Antigen in Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: Detection of ctDNA methylation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer group Patients must have histologically confirmed colorectal cancer before or after drawing blood sample. 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 chemotherapy, 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 inflammatory bowel disease. Patients who had history of other malignancies. Patients who are pregnant or breastfeeding. Alcoholic or drug abusers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer group<br>Patients with colorectal cancer. | Diagnostic Test: Detection of ctDNA methylation<br>* Detection for colorectal tumor-specific plasma ctDNA methylation markers before treatment<br>|
| Control group<br>Patients with benign colorectal disease. | Diagnostic Test: Detection of ctDNA methylation<br>* Detection for colorectal tumor-specific plasma ctDNA methylation markers before treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic sensitivity | The comparison of diagnostic sensitivity between ctDNA methylation and CEA in detecting colorectal cancer | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic specificity, accuracy, positive predictive value and negative predictive value | The comparison of diagnostic specificity, accuracy, positive predictive value and negative predictive value between ctDNA methylation and CEA in detecting colorectal cancer | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, circulating tumor DNA methylation