Colorectal CancerNCT02869269
A Study of Circulating Immune Cell Activity Changes in Blood of Colorectal Cancer Patients
An observational study of Colorectal Cancer, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
Previous studies have shown that colorectal cancer patients' prognosis and overall survival was related with immune cell expression in patients' tissue. However, the circulating immune cell activity changes in patients' blood has few studies. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Early stage and Late stage
- Type of treatment
- Medical device
- How many people
- 67 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Oct 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing colorectal surgery
Who may be able to join
- patient who was planned to undergo colorectal cancer surgery.
Who cannot join
- age < 20 years old
- history of hypersensitivity reaction in propofol or sevoflurane
- history of previous cancer
- patient with ongoing inflammation
Trial locations and contacts
1 site in 1 country.
About this study
Previous studies have shown that colorectal cancer patients' prognosis and overall survival was related with immune cell expression in patients' tissue. However, the circulating immune cell activity changes in patients' blood has few studies. The purpose of this study is to analyze the variation of circulating immune cell activity in colorectal patients' blood which is classed as clinical staging.
Read the detailed description
The patients were classed as clinical staging
- Early (stage1+2) and Late(stage3+4)
- regional lymph node metastasis
- Distant metastasis
- TNM stage
- Conditions
- Colorectal Cancer
- Being tested
- Early stage, Late stage
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early stageDevice
Also called stage1+2
patients who classed as clinical stage 1 and 2
Late stageDevice
Also called stage3+4
patients who classed as clinical stage 3 and 4
| Study group | Role | What they receive |
|---|---|---|
| Early stage | patients who diagnosed as TNM stage 1 and 2 Receives: Device: Early stage | |
| Late stage | patients who diagnosed as TNM stage 3 and 4 Receives: Device: Late stage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating helper T cell activity
change of expression level of T cell (0~100 %)
Measured: preoperative time
Secondary outcomes (1)
Cytotoxic T cell and natural killer cell activity
change of expression level Cytotoxic T cell and natural killer cell(0~100 %)from 0 to 100)
Measured: preoperative time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2016
- Study completionOct 2016
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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong-Hyop Kim, Konkuk University Medical Center
- Investigators
- Seong-Hyop Kim, M.D,Ph.D, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869269
- Sponsor's protocol ID
- KUH1160096
- Status last verified
- Jan 2018
- First submitted
- 15 Jul 2016
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Circulating Immune Cell Activity Changes in Blood of Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT02869269
- Acronym / sponsor ID
- KUH1160096
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 16 Aug 2016 (estimated)
- 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.
Previous studies have shown that colorectal cancer patients' prognosis and overall survival was related with immune cell expression in patients' tissue. However, the circulating immune cell activity changes in patients' blood has few studies. The purpose of this study is to analyze the variation of circulating immune cell activity in colorectal patients' blood which is classed as clinical staging.
Detailed description
The patients were classed as clinical staging
- Early (stage1+2) and Late(stage3+4)
- regional lymph node metastasis
- Distant metastasis
- TNM stage
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early stage | – | Device: Early stagepatients who diagnosed as TNM stage 1 and 2 |
| Late stage | – | Device: Late stagepatients who diagnosed as TNM stage 3 and 4 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing colorectal surgery
Key inclusion criteria (1 listed)
- patient who was planned to undergo colorectal cancer surgery.
Key exclusion criteria (4 listed)
- age < 20 years old
- history of hypersensitivity reaction in propofol or sevoflurane
- history of previous cancer
- patient with ongoing inflammation
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 |
|---|---|---|
| Early stageAlso: stage1+2patients who classed as clinical stage 1 and 2 | Device | Early stage |
| Late stageAlso: stage3+4patients who classed as clinical stage 3 and 4 | Device | Late stage |
Primary outcome
Circulating helper T cell activity
Time frame: preoperative time
change of expression level of T cell (0~100 %)
1 secondary outcome
Cytotoxic T cell and natural killer cell activity
Time frame: preoperative time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- 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.
Seong-Hyop Kim, M.D,Ph.D principal investigator
Konkuk University Medical Center
1 site 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 Konkuk University Medical Center at 1 site in South Korea.
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 4 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: finished, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating helper T cell activity (time frame: preoperative time). 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 29 Jan 2018.