Colorectal CancerNCT03334890
CRC Post-surgical Assessment and Recurrence Monitoring
An observational study of Colorectal Cancer, run by BioChain (Beijing) Science and Technology, Inc. at 4 sites in China.
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- plasma mSEPT9 level
- How many people
- 50 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jan 2016to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: stage II-IV CRC patients planning to performe surgery
Who may be able to join
- stage II-IV CRC patients planning to perform surgery
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
The Chinese PLA 302th hospital
Beijing
Yan Chen
Yinying Lu
- Recruiting
The Chinese PLA 309th hospital
Beijing
Lele Song, M.D.,Ph.D.
Yuemin Li
- Recruiting
The Chinese PLA general hospital
Beijing
Shaohua Guo, M.D.
Hongyi Liu, M.D.
- Recruiting
The first affiliated hospital of the Chinese PLA general hospital
Beijing
Xiumei Peng, M.D.
Wenhua Xiao, M.D.
About this study
Official title: 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.
Read the 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).
- Conditions
- Colorectal Cancer
- Being tested
- plasma mSEPT9 level
- Keywords
- colorectal cancer, septin 9, SEPT9, methylation, CEA
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma mSEPT9 levelDiagnostic test
the plasma level of methylated SEPT9
What is being measured
The primary outcome is the main question the study is designed to answer.
mSEPT9 level
the Ct values representing the mSEPT9 level in plasma
Measured: Jan 1, 2016 to Dec 31, 2017
Secondary outcomes (3)
CEA level
the serum CEA level
Measured: Jan 1, 2016 to Dec 31, 2017
tumor size
the maximal diameter of tumor measured with CT images
Measured: Jan 1, 2016 to Dec 31, 2017
CR,PR,SD,PD
complete response, partial response, stable disease, progressive disease
Measured: Jan 1, 2016 to Dec 31, 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start1 Jan 2016
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioChain (Beijing) Science and Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- 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
- Responsible party
- Principal investigator, LELE SONG, 309th Hospital of Chinese People's Liberation Army
- Investigators
- Lele Song, M.D.,Ph.D., Study director, The Chinese PLA 309th Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334890
- Sponsor's protocol ID
- SEPTMON
- Status last verified
- Nov 2017
- First submitted
- 3 Nov 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer Post-surgical Therapeutic Effect Assessment and Recurrence Monitoring by Methylated SEPT9
- ClinicalTrials.gov ID
- NCT03334890
- Acronym / sponsor ID
- SEPTMON
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, septin 9, SEPT9, methylation, CEA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- BioChain (Beijing) Science and Technology, Inc.Industry (pharma, biotech, devices)
- 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
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stage II-IV CRC patients planning to performe surgery
Key inclusion criteria (1 listed)
- stage II-IV CRC patients planning to perform surgery
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plasma mSEPT9 levelthe plasma level of methylated SEPT9 | Diagnostic test | – |
Primary outcome
mSEPT9 level
Time frame: Jan 1, 2016 to Dec 31, 2017
the Ct values representing the mSEPT9 level in plasma
3 secondary outcomes
CEA level
Time frame: Jan 1, 2016 to Dec 31, 2017
tumor size
Time frame: Jan 1, 2016 to Dec 31, 2017
CR,PR,SD,PD
Time frame: Jan 1, 2016 to Dec 31, 2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lele Song, M.D.,Ph.D. study director
The Chinese PLA 309th Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by BioChain (Beijing) Science and Technology, Inc. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lele Song, M.D.,Ph.D. (86-13240149188, songlele@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mSEPT9 level (time frame: Jan 1, 2016 to Dec 31, 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.