Clinical trial NCT03334890: CRC Post-surgical Assessment and Recurrence Monitoring
Official title: Colorectal Cancer Post-surgical Therapeutic Effect Assessment and Recurrence Monitoring by Methylated SEPT9
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: colorectal cancer
septin 9
SEPT9
methylation
CEA
Lead sponsor: BioChain (Beijing) Science and Technology, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Chinese PLA General Hospital
name: First Hospitals affiliated to the China PLA General Hospital
name: 309th Hospital of Chinese People's Liberation Army
name: Beijing 302 Hospital
First posted: 2017-11-07
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stage II-IV CRC patients planning to performe surgery

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.

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).

Eligibility 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.

Primary outcomes:
measure: mSEPT9 level
timeFrame: Jan 1, 2016 to Dec 31, 2017
Secondary outcomes:
measure: CEA level
timeFrame: Jan 1, 2016 to Dec 31, 2017
measure: tumor size
timeFrame: Jan 1, 2016 to Dec 31, 2017
measure: CR,PR,SD,PD
timeFrame: Jan 1, 2016 to Dec 31, 2017
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Chinese PLA 302th hospital
city: Beijing
country: China
facility: The Chinese PLA 309th hospital
city: Beijing
country: China
facility: The Chinese PLA general hospital
city: Beijing
country: China
facility: The first affiliated hospital of the Chinese PLA general hospital
Study officials:
affiliation: The Chinese PLA 309th Hospital
name: Lele Song, M.D.,Ph.D.
role: STUDY_DIRECTOR
References: