Colorectal Cancer Clinical Trial
Official title:
A Multi-center, Prospective Trial of the Detection of 5-hydroxymethylcytosine (5-hmC) in Plasma Cell-free DNA for Establishing a Model for the Early Diagnosis of Colorectal Cancer
In this study, the investigators establish a model for the early diagnosis of colorectal cancer based on the detection of 5-hydroxymethylcytosine (5-hmC) in training group and validate the effectiveness of the model using a validation group recruited from multiple centers.
According to precious studies, 5-methylcytosine (5-mC) and 5-hydroxymethylcytosine (5-hmC)
are both important epigenetic markers whose changes are associated with many kinds of
diseases, including cancers. This changes may help diagnose cancer. The new detection method
for 5-hmC can meet the requirements of liquid biopsy.
The traditional diagnostic methods for colorectal cancer is colonoscopy and pathology which
are inconvenient and unpleasant, and sometimes, it is difficult for the very patients to get
tissues or get enough tissues to confirm the pathologic diagnosis. In addition, other
screening methods for colorectal cancer,such as guaiac-based fecal occult blood testing and a
blood test for methylated SEPT9 DNA, have the shortcomings of relatively low sensitivity and
specificity. As a result, it is imperative to find a new detection method for early diagnosis
of colorectal cancer with the advantages of high sensitivity and specificity, minimally
invasive and convenient.
The aim of this multi-center research is to establish a model for the early diagnosis of
colorectal cancer by the detection of 5-hmC in plasma cell-free DNA. Patients who are
diagnosed with colorectal cancer by colonoscopy and pathology and not received any anti-tumor
therapy (Arm A) will be eligible for inclusion. In addition, patients who suffer with adenoma
and not received endoscopic resection (Arm B) will be eligible as well as healthy individuals
with normal colonoscopy (Arm C). Then, 5-hmC in plasma cell-free DNA will be detected and
compared among the three arms of patients (training group) to establish a model to diagnosis
other individuals (validation group) who may suffer from colorectal cancer or adenoma.
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