Validation of Useful Markers Generated by Next Generation Bio-data Based Genome Research and Cohort Study
NCT ID: NCT02807896
Last Updated: 2020-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
232 participants
OBSERVATIONAL
2016-09-30
2016-09-30
Brief Summary
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Detailed Description
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2. Effective evaluation method
The discrimination and calibration for algorithm through the diagnostic chip of each cancer type will all be examined using 10-fold cross-validation (100 repetitions). In the 10-fold cross-validation, the data is randomly divided into 10 same sized data, among which 9 are used in making a model for training and the remaining 1 is applied for test, and this process is randomly and independently repeated for 100 times.
The 10-fold cross-validated AUC is calculated to see the discrimination of diagnostic chip of each cancer type, and the 95% confidence interval is presented by non-parametric method.
The 10-fold cross-validated calibration plot is presented to see the calibration of diagnostic chip of each cancer type. The calibration plot visually demonstrate the degree of prediction by comparing the prediction probability of each group and the ratio of actual cancer patients after listing the prediction probability in the order and dividing it with regular intervals.
Then, for the same subjects, the AUC of the CA 19-9, the existing cancer diagnostic tool, is calculated and the 95% confidence interval is presented. To compare the diagnostic chip of each cancer type and the AUC of CA 19-9, p-value is calculated by non-parametric method of 10-fold cross-validated AUC.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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pancreatic cancer
pancreatic cancer 88
This study is cohort.
bile duct cancer
bile duct cancer 101
This study is cohort.
stomach cancer
stomach cancer 9
This study is cohort.
colon cancer
colon cancer 5
This study is cohort.
normal group
normal group 29
This study is cohort.
Interventions
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This study is cohort.
Eligibility Criteria
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Inclusion Criteria
* Patient age: 20\~80 years old
* Patients who voluntarily determined to participate in the clinical trial and signed the informed consent for compliance
* Korean race
Exclusion Criteria
* Patients who had treatment or surgery for cancer of other organ within 5 years before the clinical trial
20 Years
80 Years
ALL
Yes
Sponsors
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Purdue University
OTHER
LG Electronics Inc.
INDUSTRY
CHANGHEE LEE
INDUSTRY
Responsible Party
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CHANGHEE LEE
Chief Research Engineer
Principal Investigators
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Si Young Song, M.D. PhD
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital, Yonsei University
Locations
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Severance Hospital, Yonsei University
Seoul, , South Korea
Countries
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Other Identifiers
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miRNA_Chip
Identifier Type: -
Identifier Source: org_study_id
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