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

NCT02807896 | Completed DMC

• 1 other identifier: miRNA_Chip
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

BCL2 Gene mRNA Overexpression

Keywords

biomarker; pancreatic cancer; bile duct cancer; miRNA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• cut-off of each biomarker, accuracy

  within 1week

Study Arms (5)

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

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHANGHEE LEE: lead
• Purdue University: collaborator
• LG Electronics Inc.: collaborator

Study Sites (1)

Severance Hospital, Yonsei University

Seoul, South Korea

Location

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.

MeSH Terms

Conditions

Pancreatic Neoplasms; Bile Duct Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases

Study Officials

• Si Young Song, M.D. PhD

  Severance Hospital, Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Research Engineer

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: June 21, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)