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Trial record 69 of 7508 for:    Area Under Curve

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
Sponsor:
Information provided by (Responsible Party):
Chang Hee Lee, LG Electronics Inc.

Brief Summary:
Multiple biomarker development through validation of useful markers generated by next generation bio-data based genome research and cohort study

Condition or disease
BCL2 Gene mRNA Overexpression

Detailed Description:
  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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Study Type : Observational
Estimated Enrollment : 232 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
pancreatic cancer
pancreatic cancer 88
bile duct cancer
bile duct cancer 101
stomach cancer
stomach cancer 9
colon cancer
colon cancer 5
normal group
normal group 29



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The number of target subjects and calculation basis for blood samples used in the development of multiple biomarker and diagnostic chip production are as below.

Number of study subjects: 232 patients (pancreatic cancer 88, bile duct cancer 101, stomach cancer 9, colon cancer 5, normal group 29)

Criteria

Inclusion Criteria:

  • Patients with histologically or cytologically diagnosed pancreatic cancer or bile duct cancer
  • 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 with previous history of chemotherapy or radiation therapy for pancreatic cancer and/or bile duct cancer
  • Patients who had treatment or surgery for cancer of other organ within 5 years before the clinical trial

Information from the National Library of Medicine

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


Contacts
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Contact: Chang Hee Lee, PhD 82-10-6213-0669 chp.lee@lge.com
Contact: Jung Su Lee jungsu.lee@lge.com

Locations
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Korea, Republic of
Severance Hospital, Yonsei University Recruiting
Seoul, Korea, Republic of
Contact: Si Young Song, M.D. PhD       yhlee_p@naver.com   
Sponsors and Collaborators
Chang Hee Lee
Investigators
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Principal Investigator: Si Young Song, M.D. PhD Severance Hospital, Yonsei University

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Responsible Party: Chang Hee Lee, Chief Research Engineer, LG Electronics Inc.
ClinicalTrials.gov Identifier: NCT02807896     History of Changes
Other Study ID Numbers: miRNA_Chip
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chang Hee Lee, LG Electronics Inc.:
biomarker
pancreatic cancer
bile duct cancer
miRNA