An observational study in Colorectal Cancer, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-26.
Sponsored by Fudan University · Observational
In this study, the investigators establish a model for the early diagnosis of colorectal cancer based on detection of 5-hydroxymethylcytosine (5-hmC) in training group and validate the effectiveness of the model using a validation group.
Many kinds of cancers are associated with changes in epigenetics, including 5-methylcytosine (5-mC) and 5-hydroxymethylcytosine (5-hmC). 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. 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 high the advantages of high sensitivity and specificity, minimally invasive and convenient.
The aim of this research study 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 as well as healthy individuals with normal colonoscopy (Arm B). Then, 5-hmC in plasma cell-free DNA will be detected and compared between the two arms of patients (training group) to establish a model to diagnosis other people (validation group) who may suffer from colorectal cancer.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults diagnosed with colorectal cancer or with normal colonoscopy.
Arm A
Arm B
Exclusion Criteria:
Arm A
Arm B
Sensitivity and specificity of the model in the diagnosis of colorectal cancer
Sensitivity and specificity of the model in the diagnosis of colorectal cancer in training group and validation group
Time frame: 6-month
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Fudan University