Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2016-01-01
2017-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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plasma mSEPT9 level
the plasma level of methylated SEPT9
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
30 Years
80 Years
ALL
No
Sponsors
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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
Beijing 302 Hospital
OTHER
BioChain (Beijing) Science and Technology, Inc.
INDUSTRY
Responsible Party
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LELE SONG
Principal Investigator
Principal Investigators
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Lele Song, M.D.,Ph.D.
Role: STUDY_DIRECTOR
The Chinese PLA 309th Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Yan Chen
Role: primary
Lele Song, M.D.,Ph.D.
Role: primary
Shaohua Guo, M.D.
Role: primary
Xiumei Peng, M.D.
Role: primary
Other Identifiers
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SEPTMON
Identifier Type: -
Identifier Source: org_study_id