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CRC Post-surgical Assessment and Recurrence Monitoring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Chinese PLA General Hospital
First Hospitals affiliated to the China PLA General Hospital
309th Hospital of Chinese People's Liberation Army
Beijing 302 Hospital
Information provided by (Responsible Party):
LELE SONG, 309th Hospital of Chinese People's Liberation Army

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.

Condition or disease Intervention/treatment
Colorectal Cancer Diagnostic Test: plasma mSEPT9 level

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).

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: plasma mSEPT9 level
    the plasma level of methylated SEPT9


Primary Outcome Measures :
  1. mSEPT9 level [ Time Frame: Jan 1, 2016 to Dec 31, 2017 ]
    the Ct values representing the mSEPT9 level in plasma


Secondary Outcome Measures :
  1. CEA level [ Time Frame: Jan 1, 2016 to Dec 31, 2017 ]
    the serum CEA level

  2. tumor size [ Time Frame: Jan 1, 2016 to Dec 31, 2017 ]
    the maximal diameter of tumor measured with CT images

  3. 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
plasma samples from CRC patients before surgery, one day and seven days after surgery


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
stage II-IV CRC patients planning to performe surgery
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334890


Contacts
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Contact: Lele Song, M.D.,Ph.D. 86-13240149188 songlele@sina.com

Locations
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China
The Chinese PLA 302th hospital Recruiting
Beijing, China
Contact: Yan Chen         
Sub-Investigator: Yinying Lu         
The Chinese PLA 309th hospital Recruiting
Beijing, China
Contact: Lele Song, M.D.,Ph.D.         
Principal Investigator: Yuemin Li         
The Chinese PLA general hospital Recruiting
Beijing, China
Contact: Shaohua Guo, M.D.         
Sub-Investigator: Hongyi Liu, M.D.         
The first affiliated hospital of the Chinese PLA general hospital Recruiting
Beijing, China
Contact: Xiumei Peng, M.D.         
Sub-Investigator: Wenhua Xiao, M.D.         
Sponsors and Collaborators
BioChain (Beijing) Science and Technology, Inc.
Chinese PLA General Hospital
First Hospitals affiliated to the China PLA General Hospital
309th Hospital of Chinese People's Liberation Army
Beijing 302 Hospital
Investigators
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Study Director: Lele Song, M.D.,Ph.D. The Chinese PLA 309th Hospital
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Responsible Party: LELE SONG, Principal Investigator, 309th Hospital of Chinese People's Liberation Army
ClinicalTrials.gov Identifier: NCT03334890    
Other Study ID Numbers: SEPTMON
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LELE SONG, 309th Hospital of Chinese People's Liberation Army:
colorectal cancer
septin 9
SEPT9
methylation
CEA
Additional relevant MeSH terms:
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Colorectal Neoplasms
Recurrence
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Disease Attributes
Pathologic Processes