CRC Post-surgical Assessment and Recurrence Monitoring

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03334890
• Other study ID #: SEPTMON
• Status: Recruiting
• Phase: N/A
• First received: November 3, 2017
• Last updated: November 6, 2017
• Start date: January 1, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: November 2017
• Source: BioChain (Beijing) Science and Technology, Inc.
• Contact: Lele Song, M.D.,Ph.D.
• Phone: 86-13240149188
• Email: songlele[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Recurrence

Intervention

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

Locations

Country	Name	City	State
China	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

Sponsors (5)

Lead Sponsor	Collaborator
BioChain (Beijing) Science and Technology, Inc.	309th Hospital of Chinese People's Liberation Army, Beijing 302 Hospital, Chinese PLA General Hospital, First Hospitals affiliated to the China PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mSEPT9 level	the Ct values representing the mSEPT9 level in plasma	Jan 1, 2016 to Dec 31, 2017
Secondary	CEA level	the serum CEA level	Jan 1, 2016 to Dec 31, 2017
Secondary	tumor size	the maximal diameter of tumor measured with CT images	Jan 1, 2016 to Dec 31, 2017
Secondary	CR,PR,SD,PD	complete response, partial response, stable disease, progressive disease	Jan 1, 2016 to Dec 31, 2017