CRC Post-surgical Assessment and Recurrence Monitoring

November 6, 2017 updated by: LELE SONG, BioChain (Beijing) Science and Technology, Inc.

Colorectal Cancer Post-surgical Therapeutic Effect Assessment and Recurrence Monitoring by Methylated SEPT9

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.

Study Overview

Status

Unknown

Conditions

Colorectal Cancer

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- - Beijing, China
    - Recruiting
    - The Chinese PLA 302th hospital
    - Sub-Investigator:
      
      Yinying Lu
  - Beijing, China
    - Recruiting
    - The Chinese PLA 309th hospital
    - Contact:
      
      Lele Song, M.D.,Ph.D.
    - Principal Investigator:
      
      Yuemin Li
  - Beijing, China
    - Recruiting
    - The Chinese PLA General Hospital
    - Contact:
      
      Shaohua Guo, M.D.
    - Sub-Investigator:
      
      Hongyi Liu, M.D.
  - Beijing, China
    - Recruiting
    - The first affiliated hospital of the Chinese PLA general hospital
    - Contact:
      
      Xiumei Peng, M.D.
    - Sub-Investigator:
      
      Wenhua Xiao, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

stage II-IV CRC patients planning to performe surgery

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mSEPT9 level Time Frame: Jan 1, 2016 to Dec 31, 2017	the Ct values representing the mSEPT9 level in plasma	Jan 1, 2016 to Dec 31, 2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CEA level Time Frame: Jan 1, 2016 to Dec 31, 2017	the serum CEA level	Jan 1, 2016 to Dec 31, 2017
tumor size Time Frame: Jan 1, 2016 to Dec 31, 2017	the maximal diameter of tumor measured with CT images	Jan 1, 2016 to Dec 31, 2017
CR,PR,SD,PD Time Frame: Jan 1, 2016 to Dec 31, 2017	complete response, partial response, stable disease, progressive disease	Jan 1, 2016 to Dec 31, 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioChain (Beijing) Science and Technology, Inc.

Collaborators

Beijing 302 Hospital

Chinese PLA General Hospital

309th Hospital of Chinese People's Liberation Army

First Hospitals affiliated to the China PLA General Hospital

Investigators

Study Director: Lele Song, M.D.,Ph.D., The Chinese PLA 309th hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ANTICIPATED)

December 31, 2017

Study Completion (ANTICIPATED)

December 31, 2017

Study Registration Dates

First Submitted

November 3, 2017

First Submitted That Met QC Criteria

November 6, 2017

First Posted (ACTUAL)

November 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)