BCL2 Gene mRNA OverexpressionmiRNA_ChipNCT02807896
Validation of Useful Markers Generated by Next Generation Bio-data Based Genome Research and Cohort Study
An observational study of BCL2 Gene mRNA Overexpression, run by CHANGHEE LEE at 1 site in South Korea.
Trial summary
Multiple biomarker development through validation of useful markers generated by next generation bio-data based genome research and cohort study Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- BCL2 Gene mRNA Overexpression
- How many people
- 232 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2016to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
- 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.
- Conditions
- BCL2 Gene mRNA Overexpression
- Keywords
- biomarker, pancreatic cancer, bile duct cancer, miRNA
- Medical subject headings
- Pancreatic Neoplasms, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
This study is cohort.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 1week
Secondary outcomes (1)
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.
Measured: within 1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BCL2 Gene mRNA OverexpressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHANGHEE LEE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Purdue University, LG Electronics Inc.
- Responsible party
- Sponsor-investigator, CHANGHEE LEE, LG Electronics Inc.
- Investigators
- Si Young Song, M.D. PhD, Principal investigator, Severance Hospital, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807896
- Sponsor's protocol ID
- miRNA_Chip
- Acronym
- miRNA_Chip
- Status last verified
- Jan 2020
- First submitted
- 17 Jun 2016
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Biomarker Development Through Validation of Useful Markers Generated by Next Generation Bio-data Based Genome Research and Cohort Study
- ClinicalTrials.gov ID
- NCT02807896
- Acronym / sponsor ID
- miRNA_Chip / miRNA_Chip
- Conditions
- BCL2 Gene mRNA Overexpression
- Keywords
- biomarker, pancreatic cancer, bile duct cancer, miRNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- CHANGHEE LEEIndustry (pharma, biotech, devices)
- Collaborators
- Purdue University, LG Electronics Inc.
- Study start
- Sep 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple biomarker development through validation of useful markers generated by next generation bio-data based genome research and cohort study
Detailed description
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This study is cohort. | Other | bile duct cancer, colon cancer, normal group, pancreatic cancer, stomach cancer |
Primary outcome
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.
1 secondary outcome
cut-off of each biomarker, accuracy
Time frame: within 1week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Si Young Song, M.D. PhD principal investigator
Severance Hospital, Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BCL2 Gene mRNA Overexpression, run by CHANGHEE LEE at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC(area under curve) (time frame: within 1week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.