Colorectal Cancer
Conditions
Keywords
colorectal cancer, septin 9, SEPT9, methylation, CEA
Brief summary
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.
Detailed description
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).
Interventions
DIAGNOSTIC_TESTplasma mSEPT9 level
the plasma level of methylated SEPT9
Sponsors
Chinese PLA General Hospital
First Hospitals affiliated to the China PLA General Hospital
309th Hospital of Chinese People's Liberation Army
Beijing 302 Hospital
BioChain (Beijing) Science and Technology, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* stage II-IV CRC patients planning to perform surgery
Exclusion criteria
* stage 0-I CRC patients, patients with history of CRC or other cancers, patients not suitable for surgery, pregnant women, patients younger than 30 or older than 80.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mSEPT9 level | Jan 1, 2016 to Dec 31, 2017 | the Ct values representing the mSEPT9 level in plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CEA level | Jan 1, 2016 to Dec 31, 2017 | the serum CEA level |
| tumor size | Jan 1, 2016 to Dec 31, 2017 | the maximal diameter of tumor measured with CT images |
| CR,PR,SD,PD | Jan 1, 2016 to Dec 31, 2017 | complete response, partial response, stable disease, progressive disease |
Countries
China
Contacts
Primary ContactLele Song, M.D.,Ph.D.
Outcome results
None listed