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discovery and validation of biomarker predicting gastric cancer chemotherapy response
Biological biomarkers-clinical factor combined prediction model of gastric cancer chemotherapy response
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
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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| responder in palliative chemotherapy | After initial chemotherapy, responder (complete remission, partial remission) |
| |
| non-responder in palliative chemotherapy | After initial chemotherapy, disease progression |
| |
| responder in adjuvant chemotherapy | complete cure and no recurrence at least 1 year after treatment |
| |
| non-responder in adjuvant chemotherapy | non-complete cure or recurrence within 1 year after treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | Institutinal standard chemotherapy as first line : XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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<Next generation sequencing analysis> (A) palliative chemotherapy
(B) adjuvant chemotherpay
<qRT-PCR analysis> (Experimental set) (A) palliative chemotherapy
(B) adjuvant chemotherpay
(Validation set) (A) palliative chemotherapy
(B) adjuvant chemotherpay
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Su Youn Nam, MD, PhD | Contact | 82-53-200-2610 | nam20131114@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Su Youn Nam, MD, PhD | Kyungpook National University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Medical Canter | Recruiting | Daegu | 41404 | South Korea |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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RNA from gastric tissue and blood
DNA from blood
|
Combination prediction model of biologic biomarkers and clinical factors for the response of palliative chemotherapy in gastric cancer |
| up to 3 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |