CRC Post-surgical Assessment and Recurrence Monitoring
|ClinicalTrials.gov Identifier: NCT03334890|
Recruitment Status : Unknown
Verified November 2017 by LELE SONG, 309th Hospital of Chinese People's Liberation Army.
Recruitment status was: Recruiting
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
|Condition or disease||Intervention/treatment|
|Colorectal Cancer||Diagnostic Test: plasma mSEPT9 level|
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).
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Colorectal Cancer Post-surgical Therapeutic Effect Assessment and Recurrence Monitoring by Methylated SEPT9|
|Actual Study Start Date :||January 1, 2016|
|Estimated Primary Completion Date :||December 31, 2017|
|Estimated Study Completion Date :||December 31, 2017|
- Diagnostic Test: plasma mSEPT9 level
the plasma level of methylated SEPT9
- mSEPT9 level [ Time Frame: Jan 1, 2016 to Dec 31, 2017 ]the Ct values representing the mSEPT9 level in plasma
- CEA level [ Time Frame: Jan 1, 2016 to Dec 31, 2017 ]the serum CEA level
- tumor size [ Time Frame: Jan 1, 2016 to Dec 31, 2017 ]the maximal diameter of tumor measured with CT images
- CR,PR,SD,PD [ Time Frame: Jan 1, 2016 to Dec 31, 2017 ]complete response, partial response, stable disease, progressive disease
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334890
|Contact: Lele Song, M.D.,Ph.D.||firstname.lastname@example.org|
|The Chinese PLA 302th hospital||Recruiting|
|Contact: Yan Chen|
|Sub-Investigator: Yinying Lu|
|The Chinese PLA 309th hospital||Recruiting|
|Contact: Lele Song, M.D.,Ph.D.|
|Principal Investigator: Yuemin Li|
|The Chinese PLA general hospital||Recruiting|
|Contact: Shaohua Guo, M.D.|
|Sub-Investigator: Hongyi Liu, M.D.|
|The first affiliated hospital of the Chinese PLA general hospital||Recruiting|
|Contact: Xiumei Peng, M.D.|
|Sub-Investigator: Wenhua Xiao, M.D.|
|Study Director:||Lele Song, M.D.,Ph.D.||The Chinese PLA 309th Hospital|