BCL2 Gene mRNA Overexpression Clinical Trial
Official title:
Multiple Biomarker Development Through Validation of Useful Markers Generated by Next Generation Bio-data Based Genome Research and Cohort Study
Multiple biomarker development through validation of useful markers generated by next generation bio-data based genome research and cohort study
1. Objectives The study will be performed to develop the integrated analytical methods of
genomic data and clinical data and the bio-control network analysis, through which
knowledge-based integrated analysis system can be developed and then biomarker for early
diagnosis and treatment of pancreatic cancer and bile duct cancer, and finally the
customized disease management system. Also, it is to confirm the effectiveness of
diagnostic chip for research purpose by applying pancreatic/bile duct cancer-specific
biomarker, miRNA, found through the integrated analysis of genomic data and clinical
data of patients with pancreatic/bile duct cancer to the blood of patients with
pancreatic/bile duct cancer.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03627533 -
The Differences of Oocyte Maturation, Granulosa Cell Apoptosis Index Between Electroacupuncture And Sham Groups IVF
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N/A |