Predicting Biomarker of Gastric Cancer Chemotherapy Response

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Postgenome-based Systemic Discovery of Strong Biomarkers Predict Gastric Cancer Chemotherapy Response

Conditions
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Chemotherapy Effect, Gastric Cancer, Predictive Cancer Model

Intervention / Treatment
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* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| responder in palliative chemotherapy<br>After initial chemotherapy, responder (complete remission, partial remission) | Drug: Chemotherapy<br>* Institutinal standard chemotherapy as first line : XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin<br>* Other names: XP or Xelox +/- Herceptin;|
| non-responder in palliative chemotherapy<br>After initial chemotherapy, disease progression | Drug: Chemotherapy<br>* Institutinal standard chemotherapy as first line : XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin<br>* Other names: XP or Xelox +/- Herceptin;|
| responder in adjuvant chemotherapy<br>complete cure and no recurrence at least 1 year after treatment | Drug: Chemotherapy<br>* Institutinal standard chemotherapy as first line : XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin<br>* Other names: XP or Xelox +/- Herceptin;|
| non-responder in adjuvant chemotherapy<br>non-complete cure or recurrence within 1 year after treatment | Drug: Chemotherapy<br>* Institutinal standard chemotherapy as first line : XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin<br>* Other names: XP or Xelox +/- Herceptin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discovery of predicting bio-markers for gastric cancer chemotherapy response | 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 | 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 | Combination prediction model of biologic biomarkers and clinical factors for the response of palliative chemotherapy in gastric cancer | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, RNA sequencing, chemotherapy response, miRNA sequencing