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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03289988
Other study ID # 4-2017-0148
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2017
Est. completion date August 2019

Study information

Verified date January 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 964
Est. completion date August 2019
Est. primary completion date June 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Intervention

Other:
blood sampling
NK activity and gene panel expression analysis based on blood test (5cc blood sampling)

Locations

Country Name City State
Korea, Republic of Department of Internal Medicine, Yonsei University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 months
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