Validation Of Useful Markers Generated By Next Generation Bio-data Based Genome Research And Cohort Study

Study Overview

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.

BCL2 Gene mRNA Overexpression

OTHER:

miRNA_Chip

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-06-17	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-01-29
First Submitted that Met QC Criteria 2016-06-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-01-31
First Posted (ACTUAL) 2016-06-21	Results First Posted N/A	Last Verified 2020-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: pancreatic cancer pancreatic cancer 88	OTHER: This study is cohort.
: bile duct cancer bile duct cancer 101	OTHER: This study is cohort.
: stomach cancer stomach cancer 9	OTHER: This study is cohort.
: colon cancer colon cancer 5	OTHER: This study is cohort.
: normal group normal group 29	OTHER: This study is cohort.

Primary Outcome Measures	Measure Description	Time Frame
AUC(area under curve)	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.	within 1week

Secondary Outcome Measures	Measure Description	Time Frame
cut-off of each biomarker, accuracy	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.	within 1week

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:
1

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Purdue University
LG Electronics Inc.

Investigators

PRINCIPAL_INVESTIGATOR: Si Young Song, M.D. PhD, Severance Hospital, Yonsei University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record