Validation of Useful Markers Generated by Next Generation Bio-data Based Genome Research and Cohort Study (miRNA_Chip)
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|ClinicalTrials.gov Identifier: NCT02807896|
Recruitment Status : Unknown
Verified September 2016 by Chang Hee Lee, LG Electronics Inc..
Recruitment status was: Recruiting
First Posted : June 21, 2016
Last Update Posted : September 14, 2016
|Condition or disease|
|BCL2 Gene mRNA Overexpression|
- 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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||232 participants|
|Official Title:||Multiple Biomarker Development Through Validation of Useful Markers Generated by Next Generation Bio-data Based Genome Research and Cohort Study|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||September 2016|
pancreatic cancer 88
bile duct cancer
bile duct cancer 101
stomach cancer 9
colon cancer 5
normal group 29
- AUC(area under curve) [ Time Frame: within 1week ]
The AUC(area under curve) is calculated as an index for discrimination to see how well it discriminates algorithm through diagnostic chip for each cancer type.
The calibration plot will be presented for the evaluation of calibration to see how well it calibrates algorithm through diagnostic chip for each cancer type, and the comparison of CA 19-9 by each cancer type and AUC differences of the diagnostic chip will be evaluated.
- cut-off of each biomarker, accuracy [ Time Frame: within 1week ]
The cut-off of each biomarker expression for maximizing the discrimination of diagnostic chips is calculated and presented as an index for analytical sensitivity.
The accuracy considering the characteristics of diagnostic chip is calculated and presented.
Biospecimen Retention: Samples With DNA
Among patients with pancreatic cancer or bile duct cancer without previous chemotherapy or radiation therapy, the subjects are divided into operable patients and inoperable patients.
For operable patients, about 10cc (paxgene tube) of blood sample is collected before operation. After operation, 400mg of cancerous tissue and 400mg of normal tissue are requested and received from the gene bank of Severance Hospital where the tissues are stored.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807896
|Contact: Chang Hee Lee, PhDfirstname.lastname@example.org|
|Contact: Jung Su Leeemail@example.com|
|Korea, Republic of|
|Severance Hospital, Yonsei University||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Si Young Song, M.D. PhD firstname.lastname@example.org|
|Principal Investigator:||Si Young Song, M.D. PhD||Severance Hospital, Yonsei University|