- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03253107
Predicting Biomarker of Gastric Cancer Chemotherapy Response
Postgenome-based Systemic Discovery of Strong Biomarkers Predict Gastric Cancer Chemotherapy Response
discovery and validation of biomarker predicting gastric cancer chemotherapy response
- Analysis for expression level of mRNA using Next generation sequencing in gastric cancer tissue by chemotherapy response
- Analysis for expression level of miRNA using Next generation sequencing in gastric cancer tissue and blood by chemotherapy response
- Validation of mRNA and miRNA using qRT-PCR in multiple independent cohort
- Biological biomarkers-clinical factor combined prediction model of gastric cancer chemotherapy response
Study Overview
Status
Intervention / Treatment
Detailed Description
discovery and validation of biomarker predicting gastric cancer chemotherapy response
Analysis for expression level of mRNA in fresh frozen gastric cancer tissue by chemotherapy response (A) method of mRNA expression measurement: RNA sequencing (B) study group Palliative chemotherapy (inoperable patients)
institutional primary Chemotherapy regimen (XP or Xelox)
- response group
progression group
Post-OP adjuvant chemotherapy
institutional primary Chemotherapy regimen
- complete response group
- non-responder group
- and 2) groups: age, sex, regimen matched
Analysis for expression level of miRNA using Next generation sequencing in gastric cancer tissue and blood by chemotherapy response (A) method of mRNA expression measurement: RNA sequencing (B) study group
- the same patients in mRNA sequencing
- Validation of mRNA and miRNA in multiple independent cohort method of measurement of RNA expression: qRT-PCR
- Biological biomarkers-clinical factor combined prediction model of gastric cancer chemotherapy response combination of biologic biomarker and clinical factors to predict the chemotherapy response in gastric cancer
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Su Youn Nam, MD, PhD
- Phone Number: 82-53-200-2610
- Email: nam20131114@gmail.com
Study Locations
-
-
-
Daegu, Korea, Republic of, 41404
- Recruiting
- Kyungpook National University Medical Canter
-
Contact:
- Su Youn Y Nam, MD, PhD
- Phone Number: 82-53-200-2610
- Email: nam20131114@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
<Next generation sequencing analysis> (A) palliative chemotherapy
- responder (n=15)
- progression (n=15)
(B) adjuvant chemotherpay
- complete response (n=15)
- non-responder (n=15)
<qRT-PCR analysis> (Experimental set) (A) palliative chemotherapy
- responder (n=60)
- progression (n=60)
(B) adjuvant chemotherpay
- complete responder (n=60)
- non-responder (n=60)
(Validation set) (A) palliative chemotherapy
- responder (n=40)
- progression (n=40)
(B) adjuvant chemotherpay
- complete responder (n=40)
- non-responder (n=40)
1. and 2) groups: age, sex, regimen matched. Therefore this study will be nested case-control study. We will enroll 800 patients and then we will matched age, sex, and regimen in each group.
Description
Inclusion Criteria:
- new gastric cancer patients who has scheduled to start 1st cycle of chemotherapy
- patients who agreed this study and voluntarily assigned the informed consents.
Exclusion Criteria:
- patients who refused the study.
- patients who have other cancers
- heavy alcoholics
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
responder in palliative chemotherapy
After initial chemotherapy, responder (complete remission, partial remission)
|
Institutinal standard chemotherapy as first line : XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin
Other Names:
|
non-responder in palliative chemotherapy
After initial chemotherapy, disease progression
|
Institutinal standard chemotherapy as first line : XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin
Other Names:
|
responder in adjuvant chemotherapy
complete cure and no recurrence at least 1 year after treatment
|
Institutinal standard chemotherapy as first line : XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin
Other Names:
|
non-responder in adjuvant chemotherapy
non-complete cure or recurrence within 1 year after treatment
|
Institutinal standard chemotherapy as first line : XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Discovery of predicting bio-markers for gastric cancer chemotherapy response
Time Frame: up to 36 months
|
Discovery of predicting bio-markers for gastric cancer chemotherapy response using next generation sequencing and qRT-PCR
|
up to 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Combination prediction model for adjuvant chemotherapy response in gastric cancer
Time Frame: up to 5 years
|
Combination prediction model of biologic biomarkers and clinical factors for the response of adjuvant chemotherapy in gastric cancer
|
up to 5 years
|
Combination prediction model for palliative chemotherapy response in gastric cancer
Time Frame: up to 3 years
|
Combination prediction model of biologic biomarkers and clinical factors for the response of palliative chemotherapy in gastric cancer
|
up to 3 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Su Youn Nam, MD, PhD, Kyungpook National University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KNUMC 2015-10-002-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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