CRC Post-surgical Assessment and Recurrence Monitoring

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): 50

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mSEPT9 level	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	the serum CEA level	Jan 1, 2016 to Dec 31, 2017
tumor size	the maximal diameter of tumor measured with CT images	Jan 1, 2016 to Dec 31, 2017
CR,PR,SD,PD	complete response, partial response, stable disease, progressive disease	Jan 1, 2016 to Dec 31, 2017

Collaborators and Investigators

• 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

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): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: colorectal cancer; CEA; SEPT9; methylation; septin 9
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Recurrence
• Other Study ID Numbers: SEPTMON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No