Colorectal Cancer Clinical Trial
Official title:
Colorectal Cancer Post-surgical Therapeutic Effect Assessment and Recurrence Monitoring by Methylated SEPT9
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).
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