Predicting Biomarker of Gastric Cancer Chemotherapy Response
- Conditions
- Gastric CancerChemotherapy EffectPredictive Cancer Model
- Interventions
- Drug: Chemotherapy
- Registration Number
- NCT03253107
- Lead Sponsor
- Kyungpook National University Hospital
- Brief Summary
* 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
* 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)
1. response group
2. progression group
Post-OP adjuvant chemotherapy
* institutional primary Chemotherapy regimen
1. complete response group
2. non-responder group
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1. 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
- new gastric cancer patients who has scheduled to start 1st cycle of chemotherapy
- patients who agreed this study and voluntarily assigned the informed consents.
- patients who refused the study.
- patients who have other cancers
- heavy alcoholics
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description non-responder in palliative chemotherapy Chemotherapy After initial chemotherapy, disease progression responder in palliative chemotherapy Chemotherapy After initial chemotherapy, responder (complete remission, partial remission) responder in adjuvant chemotherapy Chemotherapy complete cure and no recurrence at least 1 year after treatment non-responder in adjuvant chemotherapy Chemotherapy non-complete cure or recurrence within 1 year after treatment
- Primary Outcome Measures
Name Time Method Discovery of predicting bio-markers for gastric cancer chemotherapy response up to 36 months Discovery of predicting bio-markers for gastric cancer chemotherapy response using next generation sequencing and qRT-PCR
- Secondary Outcome Measures
Name Time Method Combination prediction model for palliative chemotherapy response in gastric cancer up to 3 years Combination prediction model of biologic biomarkers and clinical factors for the response of palliative chemotherapy in gastric cancer
Combination prediction model for adjuvant chemotherapy response in gastric cancer up to 5 years Combination prediction model of biologic biomarkers and clinical factors for the response of adjuvant chemotherapy in gastric cancer
Trial Locations
- Locations (1)
Kyungpook National University Medical Canter
🇰🇷Daegu, Korea, Republic of