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| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
| First Hospitals affiliated to the China PLA General Hospital | OTHER_GOV |
| 309th Hospital of Chinese People's Liberation Army | OTHER |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| plasma mSEPT9 level | Diagnostic Test | the plasma level of methylated SEPT9 |
| Measure | Description | Time Frame |
|---|---|---|
| mSEPT9 level | the Ct values representing the mSEPT9 level in plasma | Jan 1, 2016 to Dec 31, 2017 |
| Measure | Description | Time Frame |
|---|---|---|
| CEA level | the serum CEA level | Jan 1, 2016 to Dec 31, 2017 |
| tumor size | the maximal diameter of tumor measured with CT images | Jan 1, 2016 to Dec 31, 2017 |
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Inclusion Criteria:
Exclusion Criteria:
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stage II-IV CRC patients planning to performe surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lele Song, M.D.,Ph.D. | Contact | 86-13240149188 | songlele@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Lele Song, M.D.,Ph.D. | The Chinese PLA 309th Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese PLA 302th hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Beijing 302 Hospital |
| OTHER |
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plasma samples from CRC patients before surgery, one day and seven days after surgery
| CR,PR,SD,PD | complete response, partial response, stable disease, progressive disease | Jan 1, 2016 to Dec 31, 2017 |
| The Chinese PLA 309th hospital | Recruiting | Beijing | China |
|
| The Chinese PLA general hospital | Recruiting | Beijing | China |
|
| The first affiliated hospital of the Chinese PLA general hospital | Recruiting | Beijing | China |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |