The surgical therapeutic effect of stage II-IV CRC patients will be assessed by the plasma mSEPT9 assay, and patients will be followed up by the same assay for recurrence monitoring.
Assessment of surgical therapeutic effect of colorectal cancer (CRC) relies on computer tomography (CT) and serum CEA test. CT cannot be used frequently to monitor the instant change of lesions, while CEA cannot cover all patients due to its low sensitivity. The objective of this study is to assess the performance of the methylated SEPT9 (mSEPT9) in assessing the surgical therapeutic effect of CRC. This study plans to recruit 50 CRC patients with stage II-IV CRC. Plasma samples before surgery, one day after surgery and seven days after surgery will be collected from each subject. mSEPT9 level will be measured at 3 months, 6 months, 9 months, 12 months, 18 months after surgery and relevant chemotherapy to monitor the possible recurrence of CRC. The mSEPT9 level will be measured by the Epi proColon 2.0 assay. The serum CEA will be measured parallel at the identical time points. Primary outcomes include the plasma mSEPT9 levels before surgery, one and seven days after surgery. Secondary outcomes include the serum CEA levels before surgery, one and seven days after surgery. It also includes the size of cancer for each patients, the ratio of patients with mSEPT9 complete response (CR), partial response(PR), progressive disease (PD) and stable disease (SD).
Study Type
OBSERVATIONAL
Enrollment
50
the plasma level of methylated SEPT9
The Chinese PLA 302th hospital
Beijing, China
RECRUITINGThe Chinese PLA 309th hospital
Beijing, China
RECRUITINGThe Chinese PLA general hospital
Beijing, China
RECRUITINGmSEPT9 level
the Ct values representing the mSEPT9 level in plasma
Time frame: Jan 1, 2016 to Dec 31, 2017
CEA level
the serum CEA level
Time frame: Jan 1, 2016 to Dec 31, 2017
tumor size
the maximal diameter of tumor measured with CT images
Time frame: Jan 1, 2016 to Dec 31, 2017
CR,PR,SD,PD
complete response, partial response, stable disease, progressive disease
Time frame: Jan 1, 2016 to Dec 31, 2017
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The first affiliated hospital of the Chinese PLA general hospital
Beijing, China
RECRUITING