Validation of Useful Markers Generated by Next Generation Bio-data Based Genome Research and Cohort Study (miRNA_Chip)

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

Study Overview

• Status: Completed
• Conditions: BCL2 Gene mRNA Overexpression
• Intervention / Treatment: Other

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.

• Study Type: Observational
• Enrollment (Actual): 232

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital, Yonsei University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: CHANGHEE LEE
• Collaborators: Purdue University; LG Electronics Inc.
• Investigators: Principal Investigator: Si Young Song, M.D. PhD, Severance Hospital, Yonsei University

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: June 17, 2016
• First Submitted That Met QC Criteria: June 17, 2016
• First Posted (ESTIMATE): June 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: biomarker; pancreatic cancer; miRNA; bile duct cancer
• Other Study ID Numbers: miRNA_Chip

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO