CRC Post-surgical Assessment and Recurrence Monitoring
- Conditions
- Colorectal Cancer
- Registration Number
- NCT03334890
- Lead Sponsor
- BioChain (Beijing) Science and Technology, Inc.
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- stage II-IV CRC patients planning to perform surgery
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mSEPT9 level Jan 1, 2016 to Dec 31, 2017 the Ct values representing the mSEPT9 level in plasma
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
The Chinese PLA 302th hospital
🇨🇳Beijing, China
The Chinese PLA 309th hospital
🇨🇳Beijing, China
The Chinese PLA general hospital
🇨🇳Beijing, China
The first affiliated hospital of the Chinese PLA general hospital
🇨🇳Beijing, China