Colorectal AdenomaNCT03289988
Novel Blood-based Colorectal Cancer Screening Method Using Natural Killer Cell Activity and Gene Panel Expression
An observational study of Colorectal Adenoma and Colorectal Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Natural killer cells (NK cells) are cytotoxic lymphocytes that play an important role in the innate immune system. In particular, it plays a very important defense function against host cells or cancer cells infected with a specific virus. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Adenoma, Colorectal Cancer
- What is being tested?
- blood sampling
- How many people
- 964 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2017to Aug 2019
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Normal group: patients with negative colonoscopy findings (n= 238). 2. Low risk adenoma group: patients having at least one low risk adenoma (n=250). 3. High-risk adenoma group: patients having at least one of following criteria (more thatn 1 cm in size, villous or tubulovillous histologic type, high-grade dysplasia findings) (n=316). 4. Colon cancer: histologically confirmed colon cancer patients (n=160).
Who may be able to join
- Adults population over 40 years of age
- Patients who understood this study process and agreed to participation of this study
- Colon cancer patients who have been confirmed as colorectal cancer by endoscopic biopsy within 1 month
- Colon cancer patients who received no anticancer treatment such as surgery, chemotherapy, radiation therapy after cancer diagnosis.
- Colorectal adenoma and normal control group: Patients undergoing colonoscopy for diagnostic purposes or colorectal cancer screening.
Who cannot join
- Patients who did not agree to participate in the study and did not write their informed consent
- Vulnerable subjects with mental retardation or severe psychiatric illness.
- Patients who are not appropriate enrollment of this study by researchers judgement.
- Patients who have had an immunosuppressive drug within 6 months.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 120-752
TAE IL KIM, MD, 82-2-2228-1965, taeilkim@yuhs.ac
About this study
Natural killer cells (NK cells) are cytotoxic lymphocytes that play an important role in the innate immune system. In particular, it plays a very important defense function against host cells or cancer cells infected with a specific virus. Recent studies have shown that the activity of NK cells is decreased in patients with various carcinomas compared with normal controls, suggesting that the measurement of activity of NK cells in the blood may be helpful in the early diagnosis of cancer. In a recent study analyzing NK cell activity in 762 patients undergoing colonoscopy, NK cell activity showed performance in diagnosing advanced colorectal adenoma and colorectal cancer with sensitivities 42.2% and 85.7%, and specificity 58.3% and 59.5%, respectively. This finding suggests that NK cell activity may be useful as a screening method for colorectal neoplasms. However, as a single test, this diagnostic power is relatively low. On the other hands, another blood-based colorectal cancer screening test that using 29 gene panels algorithm has recently been reported. According to this study, 29 gene panel algorithms (Colox®) showed performance in diagnosing advanced colorectal adenoma and colorectal cancer with sensitivity of 55.4% and 79.5% and specificity of both 90.0%, respectively. for diagnosis of advanced adenoma and colorectal cancer, respectively. Although the Colox® test seems to be useful for the colorectal cancer screening using blood test, this diagnostic power is relatively low. In order to overcome low diagnostic performance of aforementioned tests (NK activity and Colox®) as a single use, combination of individual biomarkers can be a promising alternative. In this regards, the aim of this study was to evaluate the diagnostic value for predicting advanced colorectal neoplasms by combining Colox® and NK cell activity indicators.
- Conditions
- Colorectal Adenoma, Colorectal Cancer
- Being tested
- blood sampling
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
NK activity and gene panel expression analysis based on blood test (5cc blood sampling)
| Study group | Role | What they receive |
|---|---|---|
| Normal group | Normal group(control group): patients with negative colonoscopy findings (n= 238). Receives: Other: blood sampling | |
| Low risk adenoma group | Low risk adenoma group: patients having at least one low risk adenoma (n=250). Receives: Other: blood sampling | |
| High-risk adenoma group | High-risk adenoma group: patients having at least one of following criteria (more than 1 cm in size, villous or tubulovillous histologic type, high-grade dysplasia findings) (n=316). Receives: Other: blood sampling | |
| Colon cancer | Colon cancer: histologically confirmed colon cancer patients (n=160). Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Power for prediction of advanced colorectal neoplasms
Diagnostic Power for prediction of advanced colorectal neoplasms using combination of conventional Colox® and NK Cell Activity Indicators.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start1 Jun 2017
- Primary completionJun 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 964 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289988
- Sponsor's protocol ID
- 4-2017-0148
- Status last verified
- Jan 2019
- First submitted
- 18 Sep 2017
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Blood-based Colorectal Cancer Screening Method Using Natural Killer Cell Activity and Gene Panel Expression
- ClinicalTrials.gov ID
- NCT03289988
- Acronym / sponsor ID
- 4-2017-0148
- Conditions
- Colorectal Adenoma, Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 964 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 21 Sep 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.
Natural killer cells (NK cells) are cytotoxic lymphocytes that play an important role in the innate immune system. In particular, it plays a very important defense function against host cells or cancer cells infected with a specific virus. Recent studies have shown that the activity of NK cells is decreased in patients with various carcinomas compared with normal controls, suggesting that the measurement of activity of NK cells in the blood may be helpful in the early diagnosis of cancer. In a recent study analyzing NK cell activity in 762 patients undergoing colonoscopy, NK cell activity showed performance in diagnosing advanced colorectal adenoma and colorectal cancer with sensitivities 42.2% and 85.7%, and specificity 58.3% and 59.5%, respectively. This finding suggests that NK cell activity may be useful as a screening method for colorectal neoplasms. However, as a single test, this diagnostic power is relatively low. On the other hands, another blood-based colorectal cancer screening test that using 29 gene panels algorithm has recently been reported. According to this study, 29 gene panel algorithms (Colox®) showed performance in diagnosing advanced colorectal adenoma and colorectal cancer with sensitivity of 55.4% and 79.5% and specificity of both 90.0%, respectively. for diagnosis of advanced adenoma and colorectal cancer, respectively. Although the Colox® test seems to be useful for the colorectal cancer screening using blood test, this diagnostic power is relatively low. In order to overcome low diagnostic performance of aforementioned tests (NK activity and Colox®) as a single use, combination of individual biomarkers can be a promising alternative. In this regards, the aim of this study was to evaluate the diagnostic value for predicting advanced colorectal neoplasms by combining Colox® and NK cell activity indicators.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal group | – | Other: blood samplingNormal group(control group): patients with negative colonoscopy findings (n= 238). |
| Low risk adenoma group | – | Other: blood samplingLow risk adenoma group: patients having at least one low risk adenoma (n=250). |
| High-risk adenoma group | – | Other: blood samplingHigh-risk adenoma group: patients having at least one of following criteria (more than 1 cm in size, villous or tubulovillous histologic type, high-grade dysplasia findings) (n=316). |
| Colon cancer | – | Other: blood samplingColon cancer: histologically confirmed colon cancer patients (n=160). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Normal group: patients with negative colonoscopy findings (n= 238). 2. Low risk adenoma group: patients having at least one low risk adenoma (n=250). 3. High-risk adenoma group: patients having at least one of following criteria (more thatn 1 cm in size, villous or tubulovillous histologic type, high-grade dysplasia findings) (n=316). 4. Colon cancer: histologically confirmed colon cancer patients (n=160).
Key inclusion criteria (5 listed)
- Adults population over 40 years of age
- Patients who understood this study process and agreed to participation of this study
- Colon cancer patients who have been confirmed as colorectal cancer by endoscopic biopsy within 1 month
- Colon cancer patients who received no anticancer treatment such as surgery, chemotherapy, radiation therapy after cancer diagnosis.
- Colorectal adenoma and normal control group: Patients undergoing colonoscopy for diagnostic purposes or colorectal cancer screening.
Key exclusion criteria (4 listed)
- Patients who did not agree to participate in the study and did not write their informed consent
- Vulnerable subjects with mental retardation or severe psychiatric illness.
- Patients who are not appropriate enrollment of this study by researchers judgement.
- Patients who have had an immunosuppressive drug within 6 months.
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 |
|---|---|---|
| blood samplingNK activity and gene panel expression analysis based on blood test (5cc blood sampling) | Other | Colon cancer, High-risk adenoma group, Low risk adenoma group, Normal group |
Primary outcome
Diagnostic Power for prediction of advanced colorectal neoplasms
Time frame: 2 months
Diagnostic Power for prediction of advanced colorectal neoplasms using combination of conventional Colox® and NK Cell Activity Indicators.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
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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.
Department of Internal Medicine, Yonsei University College of Medicine
Seoul, South Korea
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 Adenoma and Colorectal Cancer, run by Yonsei University 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 5 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: status not confirmed, as of the sponsor's last update on 15 Jan 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Power for prediction of advanced colorectal neoplasms (time frame: 2 months). 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 15 Jan 2019; AzTrials last refreshed its copy on 1 Nov 2026.